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    Delegación farmacéutica de la India en Guayaquil, Ecuador 23 de Agosto de 2010

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    Delegación farmacéutica de la India en Guayaquil, Ecuador 23 de Agosto de 2010

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    269 views16 pages

    Pharmexcil Delegation in Latin America 14-28 Aug, 2010

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    Asociación Amigos de India-Colombia
    Delegación farmacéutica de la India en Guayaquil, Ecuador 23 de Agosto de 2010

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    Uruguay, Argentina, Ecuador & Peru EP] INDIA — THE EMERGING HUB FOR HIGH QUALITY AFFORDABLE GENERICS Introduction patna The domestic pharmaceutical market size of India (at retail value excluding public | cmstenzaezwom procurement and exports), stood at approx. US$12.2bn against USS11.08bn in 2007-08 |“ growing by ahealthy 10% year on year Indian pharmaceutical industry is: © 4"inthe worldintermsof production volume @ 13°indomestic consumption value © 17°intermsof export value of bulk actives and dosage forms © Thecountryaccounts for 8% of global production and © 2%ofworld pharmaceuticals markets The exports of Drugs, pharmaceuticals & fine chemicals stood at US$8.61bn during the year 2008-09(refer chart 1). The exports grew at a compounded annual growth rate (CAGR) of 21.88% during the five year period rom 2004-05 to 2008-09. | Broadly, Asia is the largest importing region with a share of 30% of India's pharmaceutical | exports followed by Europe (24%) and North America (21%|, Africa (16%) and LAC (8%) (refer | Phaeay Source: DECI PhormesctReceorch | During 2008-09 United States of America is the top export destination valued at US$1.55bn with a share of approx. 18% in India's pharmaceutical exports followed by Russia (US$0.33on with a share of 3.84%), Germany (USSO.31bn, 3.65%), Austria {US$0.31bn,3.58%| an¢ UK (US$0.275n, 3.12%). oe Composition of India Pharmaceutical Exports In the year 2008-09, approx. 58% of India's pharmaceutical exports comprised followed by Bulk Drugs 41% and herbals exportsa share of 1% (refer chart 3 & 4) India’s Strength in Generic pharmaceuticals India is a globally acknowledged source of high quality affordable generic medicine with rich vendor base. Indias not only an API and formulation manufacturing base, the country is poised to become manufacturing hud for pharmaceutical industry of the world and an emerging hub for Contract research, Bio-technology, Clinical trials and Clinical data management. The country's pharmaceutical industry has shown tremendous progress in terms of infrastructure development, technology base creation and a wide range of production covering almost all therapeutic categories and dosage forms a RT i PT CT RT AS GT ‘As per PricewaterhouseCoopers report, finished generics supplied hae ote Wad from India account for 20% of the global generics market. It is frs"fomemiaai's a mrenaey = estimated that 70% of the patients belonging to 87 developing eee ars A a Oe 43 4 countries received medicine procured from India by the United et ae - Nations Children's Fund (UNICEF), International Dispensary [esa —feou (exopo Dioaas oy 7 Association (IDA), the Global Fund and the Clinton Foundation. Raber Coes eemeg i The country has aporox. 1,000 WHO CGMP approved eof bee br WE CEP Te id pharmaceutical plants. It has 153 European Directorate of Quelity [B¥ wa (esas Haan Fepaay Medicine (EDOM) approved manufacturing facilities among which Jemaa [ee aa tates ant Coal wr 32 sites have CEP approvals (Sep. 2008) (refer table 1). — 7 India has 1,735 (2,101) Type-lI active DMF filings with US FDA of all fede] WHD CIP Calg Foxe por Dog TB 6,482 DMs filed which is 26.76%as on Sep. 2008 (refer chart 5). {Semor EDA eed ees cies Promo’ Resaac 7 ‘As per WHO data and Pharmexcil research more than $0% of AP! approvals for ARVs, Anti-tubercular & Anti-malarials (WHO — Prequalified) are granted to India. Of the totalof 4.942 prequalified | acaceeatafana Sr te approvals granted by WHO as on Jan, 2009 to 12 countries, India has 3 highest number of approvals (621) for 6 companies. Italso has | the highest number of approvals from PEPFAR = India's Cost Advantage = India has high cost advantage in manufacturing, R&D & clinical | z trials. The cost of manufacturing in India is estimated to be half of | fs 34% i ii that of western countries and cost of conducting clinical trials are i = less than 40% to that of western countries- Chart 6 below. Strengths of Indian Pharmaceutical industry 1. Today, India offers skilled scientists/technicians/management personnel at affordable cost. Low cost of innovation / manufacturing/capex costs/ expenditure to run a cGMP complaint facility. 2, The scientific, technical and manufacturing skills, developed under the country's 3§-yeer process patent system, perfectly matches the requirements of global drug manufacturers who are increasingly seekingto many manufacturing activities previously performed in-house. 3, The country has well developed chemistry R & D and manufacturing infrastructure with proven track record in advanced chemistry capabilities, design of high tech manufacturing facilities and regulatory compliance. 4, It is known for its competency in API/Formulation Intellectual Property creation, facility design and maintenance, global regulatory affairs, legal acumen and managing international work force. 5, India not only for its traditional strengths in contract manufacturing but also as a highly attractive location for research and development (R&D), particularly in the conduct of clinicaltrials and otherservices suchas formulation development, bicequivalence testing, stability studies centers, etc. 6. India has quite a number of resourceful firms in the field of Chemistry providing high quality output in timely schedules, allowing moreleads to pursue. 7. India is significantly ahead in chemistry services such as analog preparation, analytical chemistry, focus library, combinatorial chemistry, structural chemistry, structural drug design, comouter aided crug design, high throughputscreening and assaydevelopment Indian Biotechnology Industry Currently, india holds two per cent share of the global market. With numerous comparative advantages in terms of research and development (R&D) facilities, knowledge, skills, and cost effectiveness, the biotechnology industry in India has immense potential to emerge as a global key player. According to an industry survey, carried out by the Association of Biotech Led Enterprises (ABLE), the biotechnology industry in India has notched up a growth of 18 per cent during 2008-09, earning revenues of US$ 2.67 billion. Exports accounted for nearly 60 per cent of the total business in 2008-08 and went up byalmost 25 percenttoreach US$ 1.57 billion. The domesticbusinessat USS 1.09 billion registered a 10 per cent growth in the same period. The biopharma segment continued to account for the largest share of the biotech industry's revenues. In 2008-09, the biopharma sector accounted for a 65 per cent share of the total pie with revenues of USS 1.73 billion. The bioservices sector registered a 31 per cent growth nthe period, while the bioagri sector grew by 24 per cent to reach US$ 329.33 million. The bioindustrial sector grew by 16per cent toreach US$ touch US$ 48.48 million in 2008-09. Contract Manufacturing The global market for contract manufacturing of prescription drugs is estimated to increase from a value of $26.2 billion to $43.9 billion. Asia has recently been challenging North America & Europe's traditional domination of the global pharmaceutical contract manufacturing market. India's entrepreneurial pharmaceutical manufacturers are now beginning to leverage benefits from the introduction ofthe nation's product patent system. Thescientific, technical and manufacturing skills, developed under the country's 35-year process patent system, perfectly matches the requirements of global drug ‘manufacturers whoare increasingly seeking tooffshore many manufacturing activities previously performed in-house. 105.34million andthe bioinformatics sector grewby 15 per cent to Contract Research Contract research in generic pharmaceuticals is also a significant opportunity. Established generic companies would like to outsource or buy services in formulation development, bioequivalence testing, stability studies centers, etc. Various surveys indicate that India has quite a number of resourceful firms in the field of Chemistry providing high quality output in timely schedules, allowing more leads to pursue. India is significantly ahead in chemistry services such as analog preparation, analytical chemistry, focus library, combinatorial chemistry, structural chemistry, structural drug design, computer aided drug design, highthroughput screening and assay development. Medical Tourism The medical tourism market in india was estimated at US$333 million in 2004, growing by about 25 percent and this is predicted to become a USS2 billion-a-year business opportunity by 2012. India is witnessing a surge of patients from developed countries as well as from Africa, South & West Asia because while the cost of comparable treatment in India is about 1/8th to 1/Sth of the cost in the Western countries, the quality of Indian healthcare delivery (in certain institutions) is worldclass. Exports of Herbal, Ayurvedic, Siddha, Unani & Homeopathic Products India with its exports of US$85.9%mn is considered as the major source exporting country for Herbal medicines. Indian exports of medicinal plants grew at 8% during 2006 over 2005. Patent Protection ‘The new patent regime has also led to the return of the pharmaceutical multinationals, many of which had left india during the 1970s. Now they are back and are looking at Indianot only for its traditional strengthsin contract manufacturing but also as @ highly attractive location for research and development (R&O), particularly in the conduct of clinical trials and other services, The countryis therefore poised to become global manufacturing hub for pharmaceuticalindustry. India's Drug Regulatory System India has a well developed drug regulatory system, The Central Drug Standards Control Organization (CDSCO) set up under Ministry of Health & Family Welfare, Government of india isthe Apex drug regulatory & licensing agency inthe country. The organization headed by Drug Controller of India (DCG!) and is responsible for Standards of Drugs, Market authorizations, clinical trails, Import licenses, cGMP, monitoring of quality of drugs & cosmetics manufactured, pre & post licensing inspections, etc. Department of Pharmaceuticals under Ministry of Chemicals & Fertilizers is responsible for Pharmaceuticals policy and regulation including price regulation. Further, there are state level Drug Control Authorities to inspect and monitor pharmaceutical manufacturing facilities. Someimportant laws related to Pharmaceutical sector in india are. ‘The Drugsand Cosmetics Act, 1940 © ThePharmacy Act, 1948 Foreign Trade (Development & Regulation) Act 1992 @ Foreign Exchange Management Act & RBIRegulations Customs Act 1962, Customs Tariff Act © Central Excise Act 1994 & Rules, ‘The Trade and Merchandise Marks Act, 1958 © TheIndian Patent and Design Act, 1970 ‘The Drugs and MagicRemedies (Odjectionable Advertisement) Act, 1954 The Narcotic Drugs and PsychotropicSubstances Act, 1985 ‘The Medicinaland Toilet Preparations (Excise Duties) Act, 1956 ‘The Drugs (Prices Control] Order 1995 (under the Essential Commodities Act) The overall objective of a National Regulatory Authority (NRA) isto ensure that medicinal products are of acceptable quality, safety and efficacy, are manufactured and distributed in ways which ensure their quality until they reach the patient/consumer, and their commercial promotion is accurate. The Drugs and Cosmetics Act of India has laid down that standards of quality of drugs shall be as given in the second schedule to the Act. Any drug including API should conform to the specifications of the prescribed pharmacopoeias or those claimed on the label. In addition, patent and proprietary medicines, Surgical designs, Medical Devices, Mechanical Contraceptives are required to comply with the requirements of the national rules. Astudy of samoles of drugs tested all over the country in last 5 years by the State Drug Controllers in various states of India, revealed that about 0.3% to 0.4% of around 40,000 samples fell within the category of spurious drugs. Any product exported from india can only be shipped after due to inspection by DRA official oosted at Customs ports of the country. India has therefore effective export controls for regulating counterfeit products. About Pharmaceuticals Export Promotion Council Pharmaceuticals Export Promotion Council of India (popularly known as PHARMEXCIL) has been sponsored by the Ministry of Commerce & industry, Department of Commerce, Government of India to represent the Drugs & Pharmaceuticals and Healthcare Industry in the global arena. PHARMEXCIL is mandated to help its members to achiave excellence in export and facilitate overseas buyers to find suitable trade partners from Indian Pharma Industry, To achieve these objectives PHARMEXCIL initiates various export promotional activities for the benefit of the exporting community of the Pharma Products suchas, © Dissemination of Trade Enquiries, © International Trace Statistics, © Invite Business/Trade delegations fromoverseastolndia Technical Publications, ‘© Organizing Buyers SellersMeet both inindia and overseas, @ Exporters Directory © Organizing and Participating in International Trade Fairs, © Organizing Trade/Business delegations from Indiato overseas markets © Provide Policyinoutsto Government departments to facilitate exports from India, © Mediate between various Government Departments & exporters to resolve operational problems confronting the exporters, ‘© Organize National and International seminarsrelating to Pharma products, R & D and pharma related services. PHARMEXCIL acts as a single contact point for the overseas buyers and investors by providing list of manufacturers / exporters of the Pharma Products of interest to them, provides assistance in co-ordinating appointments for the overseas buyers/investors during their visits to India through its offices at Hyderabad, Mumbai and New Delhi. PHARMEXCIL arranges for visits to manufacturing facilities, research institutes and meetings for overseas buyers with the exporting community for mutual exchange of ideas and information. PHARMEXCIL will offer any other services to be a facilitator for building mutually beneficial relationship between the overseas buyers/investors and their Indian counterparts to promote export of Pharmaceutical products and services from India. PHARMEXCILis the designated Authority for Drugs & Pharma Sector dealinginProducts/ Services like, © Bulk Drugs (APIs) © Drugintermediates = Drug Formulations @ Biotechnology © Biological Products © Medicinal Plants Product ¢ Homeopathy © Diagnostics © Contract Research © Clinical Research © Collaborative Research @ Surgical Dressings © Technologies / Consultancy Contract Manufacturing © Nutraceuticals & Phytochemicals. © Pharmaceutical Industry Related Services © Herbal Products (Ayurveda, Siddha & Unani) © Herbal Products (Ayurveda, Siddha & Unani) INDIA - El Hub emergentes para el genéricos asequibles de Alta calidad Introduccién El tamafio del mercado interno farmacéutica de la India (en valor al por menor excepto la contratacin piblica y las exportaciones), se situa on aprox. Délares de los EE.UU. 12.2bn contra délares delos E€,UU. en 2007-08 11.08bn creciendo a un saludable 10% afto trasafo. Laindustria farmacéutica India es la siguiente: . © 42en el mundo en términos de volumen de produccién 13° enelvalor del consumo interno . . . 178 en términos de valor de las exportaciones a granel de activos y formas farmacéuticas Fl pals representa el 8% de la produccién mundial y ar 2% de los productos fermacéuticos mercados mundiales eee Las exportaciones de medicamentos, productos farmacéuticos y productos quimicos finos se = situs en délares de los EE.UU. 8.61bn durante el efio 2008-09 (consulte el grifico 1). Las exportaciones crecieron a una tasa de crecimiento anual compuesta (CAGR) del 21,98% durante elquinquenio 2004.05 2 2008-08. sou 066% rh Reh En términos generales, Asia esla mayor region importadora, con una cuota del 30% de las exportaciones farmacéuticas dela India seguida por Europa (24%) yNorteamérica (21%|, Africa (162) y América Latina (8%) (vSaseel grdfico 2) Durante 2008-09 los Estados Unidos de América es el destino de las exportaciones superior por valor de FE UU. $ 1.55bn con una cuota de aprox. 18% de las exportaciones farmacéuticas de la India, seguido por Rusia (EE.UU. $ 0.33bn con una cuota del 3,84%6), Alemania (EE.UU. $ 0.31bn, 3,65%), Austria (EE.UU. $0.310n, 3,58%) y ReinoUnido (en délares EE.UU.0.27bn, el 3,12%) Compo: de las exportaciones de productos En el afio 2008-09, aprox. 587% de les exportaciones farmacéuticas de la India compuesta seguica de crogas a granel el 41% y las, exportaciones de productos naturales una cuota del 1% (ver grdfico3y4) Fuerza de la India en productos farmacéuticos genéricos: La India es un reconocido a nivel global fuente de alta calidad de los medicamentos genéricos asequibles, con base de proveedores ricos. India no es solo una base de fabricacion de la API y la formulacién, el pais esta listo para convertirse en centro de fabricacién para la industria farmacéutica del mundo y un centro de investigacin emergentes del contrato, Bio- tecnologia, ensayos clinicos y de gest tremendoen términos de desarrollo de lainfraestructura, la creacién de base tecnolégica y una amplia gama de produccion abarca casi todaslas categorias y formas de dosificacién terapéutica én de datos clinicos. industria farmacéutica del pais ha mostrado un progreso Segiin informe de PricewaterhouseCoopers, terminé genéricos suministrados desde Ia India representan el 20% del mercado global de genéricos. Se estima que el 70% de los pacientes pertenecientes a 87 paises en desarrollo recibieron medicamentos adquiridos en la india por el Fondo de las Naciones Unidas para Ia Infancia (UNICEF), Intemational Dispensary Association (IDA|, el Fondo Mundial y la Fundacién Clinton. El pais cuenta con aprox. 1000 la OMS aprobé CGMP plantas farmacéuticas. Cuenta con 153 Direccién Europea de Calidad Medicina (EDQM) aprobs las instalaciones de fabricacién entre los cuales 32 tienen sitios de idoneidad del PAC (Sep. 2008) (consulte el cuadro1}, Tas Ape ai paras oprass racUT TA scaneasreulsdrasdelmnde County | Pals Nombre el Ea Roqulndor Nos. Wax: EEUU. | DVForcronado an la FDA da EEUU. ce ‘DWF pesenad® amie FOR 36 EEO 1a {rtaases) Niner. de malas aoe 30 aare en ar Dil se tanareseiade ermine ebeSmianos Wana! DG EDGuEDDKI Diesabn Euopoo de 7 ae an etincons oon Niner PEC [a ae 00 fniecass goo OE Ta BOE 1 ‘naariod cn BOOM FUTUR) Raine Undo MRA (genset de F Nedearerice' do. Sake) Faro Unie (enoescs) lope | DNGK haninvadoe_— Orage 7 mF ‘uontad aor toni amprees) “Tenaria—[ (FDA) Tareana Aided Alvis 7 7 Necicanertc eneress) Tiss BPM ew ONS Caton FSR (OE “0 onto Carol de oat. i) Eis Seiwa ea FBX eo pata ane a La India tiene 1.735 (2101) Tipo Il activa presentaciones DMF con la FDA de EE.UU, de todos los 6.482 que se presentaron DMF 26,76%comoen septiembre 2008 (ver grafico 5). Segin datos de la OMS y |a investigacion Pharmexcil mas del 90% de las aprobaciones API de antirretrovirales, anti- tuberculosos y Anti-malaria (precalificada por la OMS) se conceden a ia India. Del total de 4.942 autorizaciones concedidas precalificados por la OMS como en enero de 2009 a 12 paises, la India tiene la tercera mayor nimero de aprobaciones (621) por 6 empresas. También tiene el mayor nimero de aprobaciones de PEPFAR, Ventajas de Costo de Ia In India tiene ventaja decostes de alta en la fabricacién,|+D-+ensayos clinicos. El coste de fabricacién enlaindia se estimaen la mitad de la de los paises occidentales y el costo de la realizacién de ensayos clinicos son menos del 40% a la de los paises occidentales- Grafico6 a continuacién. ‘Gare eaunerz wes Hoof pet Actes Ors (Ge Comparion of Gat vente la) SSP ciao aa RT eS a an \dustria farmacéutica indi India tiene ventaja de costes de alta en la fabricacién, 1+ D+ensayos clinicos. Fl caste de fabricacién enlaindia se estima ena mitad de la de los paises occidentales y el costo de la realizacién de ensayos clinicos son menos del 40% a la de los paises occidentales- Grafico6 a continuacién. 1. Hoyen dia, la India ofrece a cientificos calificados / técnicos / gestién de personal a un costo asequible. Bajo costo de la innovaciény manufactura Gastosde gasto de capital y gastos para ejecutar una instalacion de queja CGM? 2. Elcientifico, técnico y las capacidades productivas, desarrollada bajo el sistema nacional de proceso de 35 afios de la patente, encaja perfectemente con los requisitos de los fabricantes de drogas a nivel mundial que estan buscando cada vez més 2 costa muchas actividades manufactureras que antesse realizabaninternamente. 3. Elpaisha desarrollado la quimica de |+ D y la infraestructura de produccién con experiencia probada en las capacidades de quimicaavanzada, disefiode instalaciones de fabricacion de alta tecnologiay el cumplimiento regulatorio. 4. Esconocido por su competencia en API/ creacién de Formulacién de la Propiedad Intelectual, disefia ymantenimiento deinstalaciones, de asuntos regulatorios globales, la perspicaciajuridica y la gestidn dela fuerza de trabajo intemmecional 5. Indie no sélo por sus tradicionales fortalezasen Ia fabricacion de contrato, sino también como unazona ce granatractivo para la investigacién y desarrollo (I + D}, especialmente en la realizacién de ensayos clinicos y otros servicios como el desarrollo dela formulacién, pruebas de bioequivalencia, estudiosde centros de estabilidad, etc 6. Lalndia tiene un buennimero de empresas derecursosen el mbito de la Quimica proporcionar alta calidad desalidaen las listasa tiempo, permitiendo quemés|leva acabo. 7. La India esta significativamente por encima de los servicios de la quimica como la preparacin analégica, quimica analitica, a coleccién de enfoque, la quimica combinatoria, quimica estructural, disefio de farmacos estructural, disefio de férmacos asistido por computadora, el cribado de alto rendimiento y desartollode ensayos. Sector de la biotecnologia indi Actualmente, la India cuenta con dos por ciento (2%) de participacién de! mercado global. A través de numerosas ventajas comparativas en términos de investigacién y desarrollo (I+ D) instalaciones, los conacimientos, habilidades, ylarentabilidad, la industria de la biotecnologia en la India tiene un inmenso potencial para emerger como un actor clave global. De acuerdo con una encuesta de la industria, llevada a cabo por la Asaciacién de Empresas de biotecnologfa Led (AEBA), la industria de la biotecnologia en la India ha ganado una crecimiento del 18 por ciento durante 2008-09, ganando unos ingresos de 2,67 mil millones délares FE UU. Las exportaciones representaron casi el 60 por ciento del negccio total en 2008-09 y aumenté en un 25 por ciento casi de llegar a EE.UU. $ 1,570,000,000. £1 negocio doméstico a 1,09 mil millones délares EE.UU. registré un 10 por ciento de crecimiento enelmismo periodo. El segmento de biofarmacéutica siguieron representando la mayor proporcién de los ingresos de la industria de la biotecnologia. En 2008-09, el sector biofarmacéutico representan un 65 por ciento de las acciones de la torta con unos ingresos de 1,73 mil millones délares EE.UU.. Ei sector ragistré un bioservices 31 por ciento de crecimiento en el periodo, mientras que el sector creci bioagri enun 24 por ciento para llegar a EE.UU. 329,33 millones délares. El sector crecié bioindustriales en un 16 por ciento para llegar a EEUU. 105,34 millones délares y el sector bioinformética uments un15 porcientode tocar 48,48 millones dolares EE.UU. en 2008-09. Fabricacién por Contrato El mercado mundial de fabricacion por contrato de medicamentos con receta se estima que aumentard a partir de un valor de 26,2 mil millones délares a 43,9 mil millones dolares. Asia ha estado desafiando América del Norte y Europa la dominacién tradicional del mercado global de fartmacéuticos de fabricacién por contrato, Empresarial fabricantes de productos farmacéuticos de la India estén comenzando a aprovechar los beneficios de la introduccién del sistema nacional de patentes de productos. El cientifico, técnico y las capacidades productivas, desarrollada bajo el sistema nacional de proceso de 35 afios de la patente, encaja perfectamente con los requisitos de los fobricantes de drogas a nivel mundial que estan buscando cada vez mas a costa muchas actividades manufactureras que antes se realizaban internamente. Contrato de Investigacién Investigacién por contrato de productos farmacéuticos genéricos es también una oportunidad significativa. Establecida las empresas de genéricos gustaria subcontratar o contratar servicios en el desarrollo de formulacién, pruebas de bioequivalencia, estudiosde centros deestebilidad, ete Varios estudios indican que la India tiene un buen numero de empresas de recursos en elmbito de la Quimica proporcionar alta calidad de salida en as listasa tiempo, permitiendo que mds lleva cabo. La India esta significativamente por encima de los servicios de la quimica como la preparacién analégica, quimica analitica, la coleccién de enfoque, la quimica combinatoria, quimica estructural, dise‘ic de farmacos estructural, disefio de férmacos asistido por computadora, el cribado de alto rendimiento y desarrollo deensayos. Turismo Médi Elmercado del turismo médico en [a India se estimd en 333 millones délares EE.UU. en 2004, creciendo un 25 porcientoy se prevé para convertirse en délares de los EF.UU. ? mil millones de afios-la oportunidad de negocio para el afio 2012. La India estd siendo testigo de una oleada de pacientes de palses desarrollados, asi como de Africa, Asia meridional y Asia occidental porque mientras que el costo del tratamiento comparable en la India est a punto de 1/80 1/50 de los costos en los paises occidentales, la calidad delos indios prestacién de asistencia sanitaria (en algunas nstituciones) es de clase mundial Las exportaciones de hierbas, Ayurveda, Siddha, Unani y los productos homeopaticos India, con sus exportaciones de ddlares de los EE,UU. 85.98mn se considera como la fuente principal pais exportador de hierbas medicinales. lasexportaciones indias de las plantas medicinales crecié aun 8% durante 2006 respecto a 2005, Proteccién de Patentes El nuevo régimen de patentes también ha dado lugar @ la devolucién de las multinacionales farmacéuticas, muchos de los cuales habian abandonado la India durante la década de 1970. Ahora estan de vuelta y que busca.en la Indiano sdlo por sus tradicionales fortalezas en la fabricacién de contreto, sino también como una zona de gran etractivo para la investigeciSn y desarrollo (I + D), especialmente en la realizacién de ensayos clinicos y otros servicios. El pais esta listo para convertirse en centro de produccién mundial paralaindustria farmacéutica Sistema regulador de medicamentos de la India India tiene un sistema bien desarrollado de reglamentacion de medicamentos. La Central de Normas de Control de Drogas Organizacién (CDSCO) establecido por el Ministerio de Salud y Bienestar Familiar, Gobierno de la India es la droga de Apex agencia reguladoray de concesién de licencias en el pafs. La organizacién encabezada por el Contralor de Drogas de la India {DCGI) yes responsable de las normas de las drogas, las autorizaciones de comercializacién, ensayos clinicos, certificados de importacién, el CGMP, el control de calidad de los medicamentos y los cosméticos fabricados, pre y post inspecciones de licencias, etc. Departamento de Farmacia a cargo del Ministerio de Productos Quimicos y Fertilizantes responsable de la politica y la regulacién de productos farmaceuticos incluyendo la regulacién de precios. Ademds, no haya nivel estatal de Control de Drogas autoridades de inspeccionar ysupervisaras instalaciones de fabricacion farmacéutica Algunas leyes importantes relacionados con el sector farmacéutico en la India son los siguientes: © LaLeyde Drogas y Cosméticos de 1940 © LaLeydeFarmacia, 1948 Comercio Exterior (Desarrollo y Reglamentacién) de 1992 @ Ley del régimen de cambio y RBI Reglamento Ley de los Impuestos Especiales Central 1994 y Reglamento, @ Ley de Aduanas de 1952, Ley de Aduanas arancel Elcomercio de mercancias y Ley de Marcas de 1958 © LaLey de Patentes de la India y Disefio, 1970 Las drogas y remedios magicos (Publicidad de dudosa reoutacién), de 1954 La Ley de Estupefacientes y Sustancias Sicotrépicas de 1985, Los medicamentos y productos de tocador {impuestos especiales), 1956 La Droge (Precios control) de 1995 (en virtud de la Ley de los productos bésicos) El objetivo general de una autorided nacional de reglamentacién [ANR) es asegurar que los medicamentos sean de calidad aceptable, seguridad y eficacia, se fabrican y distribuyen de manera que garanticen su calidad hasta que lleguen al paciente / consumidor, asf comasu promacién comerciales preciso. La Ley de Drogas y Cosméticos de la India ha establecido que lasnormes de calidad de los medicamentos seré el indicado en el segundo anexo de Ia ley, Cualquier medicamento incluyendo API debe ajustarse alas especificaciones de las farmacopeas prescrito o los reclamados en la etiqueta. Ademds, las patentes y los medicamentos patentados, los disefios quirtirgicos, dispositivos médicos, anticonceptivos mecdnicos estan obligados a cumplircon los requisitosde las normas nacionales. Un estudio de muestras de drogas probadas en todo el pais en los ultimos 5 afios por los controladores Estatal de los Medicamentos en varios estados de la India, revelé que alrededor del 0,3% al 0,4%de losalrededor de 40.000 muestras cay dentro de la categoria de medicamentos falsos. Cualquier producto exportado de la India sélo puede ser enviado después debido 2 la inspeccién por agentes del DRA publicado en los puertos de Aduanas del pais. India, por lotanto los controles de exportacidn eficaces parala regulacién delafalsificacién de productos. Sobre los productos farmacéuticos de exportacion Consejo de Promocién (Pharmaceuticals Export Promotion Council of India) (Popularmente conocido como PHARMEXCIL) ha sido patrocinado por el Ministerio de Comercio e Industria, Departamento de Comercio del Gobierno de la India pare representar a la Droga y Farmacéutica e Industria dela Salud enel mbito mundial PHARMEXCIL tiene el mandato de ayudar a sus miembros para lograr la excelencia en la exportacién y facilitar los compradores extranjeros para encontrar socios adecuados de comercio dela India de la Industria Farmacéutica, Para lograr estos objetivos PHARMA inicia la exportacién diversas actividades de promocién en beneficio de la comunidad de exportadores de los productos farmacéuticos talescomo: Difusionde Consultasde Comercio, Estadisticas del Comercio Internacional, Organizacion de Comercio/ Negocios delegaciones de la Indiaalosmercados de ultramar Invitaralos negocios / Comercio delegaciones del extranjero alaindia Los compradores Organizador vendedores se encuentran tanto en india comoen el extranjero, Organizecién yperticioacién en feriascomerciales internacionales, Publicaciones técnicas Directoriode Exportadores Proporcionar los insumos de politica para los departamentos del Gobierno para facilitar as exoortaciones de la India, Mediar entre los distintos departamentos gubernamentales y los exportadores a resolver los problemas operativosque enfrentan|os exportadores. © Organizer seminzrios nacionales e internacionales relativas a los productos de Pharma, R + D farmacéutica y servicios relacionados. PHARMEXCIL actiia como un punto de contacto tinico para los compredores de ultramar y los inversores al proporcionar la lista de fabricantes y exportadores de los Productos Pharma de interés para ellos, presta asistencia en la coordinacion de citas para los compradores en el extranjero e inversionistas durante sus visitas a la India a través de sus oficinas en Hyderabad, Mumbai y Nueva Delhi. PHARMEXCIL organiza visitas a las fébricas, institutos de investigacién y reuniones para los compradores extranjeros con la comunidad de exportadores para el intercambiomutuo de idease informacion. PHARMEXCIL ofrecerd otros servicios para ser un facilitador para la construccién de relaciones mutuamente beneficiosas entre los compradores extranjerose inversionistasy sus homologos de la India para promover la exportacién de productos y servicios farmacéuticosde la India, PHARMEXCIL ha sido cesignado como Autoridad de la droga y del sector farmacéutico la negociacién de productos / servicios como, © Drogasagranel (API) © Intermediariosde Drogas © Formulacién de Drogas © Biotecnologia @ Productos Biol6gicos © Plantas Medicinales de productos © Homeopatia © nutracéuticos y fitoquimicos © Diagnéstico © Contrato de investigacién © Fabricacién de Contrato © Investigacion Clinica © Los apésitos quirdrgicos © Tecnologias / Consultoria © Productos a base de plantas (Ayurveda, Siddha yUnani) © — Colaboracién en Investigacién © Servicios relacionados con el Industria Farmacéutica AADIVIGHNESH CHEM PVT. ITD. A/7,Badrinath Apartment, Shimpoli Road, Borivali (W), Mumbai-400092, India. APEX DRUG HOUSE 28, Mehta Vora Chambers {Mahendra Mansion), Babu Genu Road, Mumbai- 400002, India. Tel: +91-22-22077266/ +91-22-22086900 Fax:+91-22-22086900 E-mail: raj@adh.co.in Website: www.apexdrugsindia.com Name ofthe delegate: Mr. Rajesh Bhayani Designation: Director ‘Company Profile: Apex Drugs House isa manufacturer of generics and branded generics exporting to South ‘America, Africa, Far East and Middle East. They have Oral, Company Profile: Aadivighnesh Chem Pvt. Ltd. is a Injectables, Liquid Orals & Topicals facilities. They can manufacturer and exporter of pharmaceutical raw Provide registration dossiers with CTD format and BA/BE | material & finished formulation where required, their manufacturing facilities are WO- | GMP approved and follow strict validation process for For more details please visit our web site every stage of manufacturing & quality control. They are Tel: 191-22-28926417 / +91-22-28923618 Fax: +91-22-28920082 E-mail:sales@aadivighnesh.com,aadi@vsnl.net Name of the delegate: Mr. Shah Devang Bipinbhai Designation: Director weww.eadivighnesh.com an ISO 9001:2000 certified company and “A government of India recognized export house” by the ministry of ‘commerce. They manufacture generics in the client's brand as required in the country of import. Products: Finished Formulations, Active Pharmaceuticals Ingredients, Antibiotics, Drug Delivery systems and | Excipients. : For more details please visit our web site www apexdrugsindia.com AXON DRUGS PVT. ITD. AUROCHEM LABORATORIES (1) PVT. LTD. 333, Gundecha Industrial Complex, Akurli Road, Kandivali(E), Mumbai-400101, India. Tel: 491-22-42508181 Fax: +91-22-28873236 E-mail: aurochem@mtnl.net.in, aurochem@vsnl.in, info@aurochemlaboratories.com Website: www.aurochemlaboratories.com Name of the delegate: Mr. Dipak Desai Designation: Director Company Profile: Aurochem is a leading manufacturer and exporter of finished formulations in Tablets, capsules, Oinment/Creams and Liquids/Syrups forms. Aurochem has a rare distinction of manufacturing more than 450 products in its facilities, which are WHO-GMP accredited across the world. K-95, k Block, 16th Street, Annanagar East, Chennai- 600 102, India. Tel: +91-44-42171424/ +91-44-42171425 Fax: +91-44-43500673 | E-mail: info@axondrugs.com Website: www.axondrugs.com Name of the delegate: Mr. Damodaram Harirajan | Designation: Managing Director Company Profile: Axon Drugs Pvt. Ltd, isa manufacturer exporters of Pharmaceuticals Formulations with a unit situatedatabout 25kis from Chennai. Aurochem have varied product range in the Therepeutic segment. which ranges from Cardiovascular, Anti- Diabetics, Anti-Malaria, NSAIDS, Anti-Bacterial, Impotence drugs, Lipid lowering drugs, Anti-ulcer, Neuro-psycotropics, Dermatologicals, Vitamins and Antiretroviral. The new product range that has been introducedis the Cosmetics and Nutraceuticals. For more details please visit our web site ‘www.axondrugs.com For more details please visit our web site www.aurochemlaboratories.com CORAL LABORATORIES LTD. 38, Patanwala Ind, Estate, Opp. Shreyas Cinema, L.8.S Marg, Ghatkopar (W), Mumbai- 400 086, India. Tel: 491-22-25005245 /+91-22-25005245 Fax: #91-22-25004893 E-mail: exports@corallab.com Website: www.coraliab.com Name of the delegate: Mr. Dhameja Girish Madan Designation: Asst. Manager ~ Exports Name of the company: Coral Laboratories Ltd. is one of the reputed Manufacturer & Exporter having certification of WHO GMP and {SO 9001:2000 exporting in more than 28 countries. They manufacture all dosages like Tablets, Capsules, Liquids, Dry Syrups, Cream, Ointment, Powder, External Preparation Gel and also have separate facility for Betelactum and low RH products. Coral has a wide range of products in key therapeutic segments such as Antibiotics, Antibacterial, Vitamin Supplement, Iron Supplement, Antacid, Antiulcer, Antispasmolic, Analgesic, Antipyretic, Expectorant, Cardiac Medicines, Herbal Medicines, Tropical preparations. They also undertake Contract Manufacturing and Third Party Manufacturing for local and export market. For more details please visit our web site www.corallab.com FOURRTS (INDIA) LABORATORIES PVT. LTD. Plot no. 2, Fourrts Avenue, Annai Indira Nagar, Okkiyam Thoraipakkam, Chennai -600097, India. Tel: 491-44-24581899 / +91-44-24581199 Fax: #91-44-24581199 E-mail: export@fourrts.com, Website: www.fourrts.com Name of the delegate: Mr. Bhammar Kaushik Designation: Asst. General Manager - International Company Profile: Fourrts (India) Laboratories Pvt. Ltd are one of the leading finished pharmaceutical formulation dosage manufacturer and exporter based at Chennai, South India. Fourrtsis in business for more than three decades and have ISO Certified; WHO-GMP approved manufacturing facility for Tablets, Capsules, Liquids Orals, Creams, Ointments and Medicated Toothpaste. Their R&D is approved by Department of Science and Technology, Government of India. They are recipients of 7 times Quality Excellence Awards instituted by All India Drug Manufacturers Association, Managerial Excellence Award from Madras Management Association, 5S certification and Industrial Safety award For more details please visit our web site www-fourrts.com = DWD PHARMACEUTICALS LTD. 4° Floor Dalamal House, 1.8. Road, Nariman Point, Mumbai~400021, india. Tel: +91-22-22853910/ +91-22-22853911 Fax:+91-22-22825753 E-mail: exports@corallab.com Website: www.corallab.com Nameof the delegate: Mr. Doshi Chetan Navinchandra | Designation: CEO Company Profile: DWD Pharmaceuticals Ltd. is one of | the 100 Companies of ORG Ranking and has an Ethical Promotion throughout the country. Being a Merchant Exporter DWD aims at exporting the best quality products and establishes their presence in International Markets. They cover all the dosage forms viz. Tablets, Capsules, Liquids, Dry Syrups, Cream, Ointments, Dry Powder, Injectables & Sterile Products (including Betalactum and Cephalasporins).. For more details please visit our web site www.corallab.com | | IDEAL CURES PVT. LTD. | 6th Floor, Elecon Chambers, Andheri KurlaRoad, Andheri(E), Mumbai-400072, India. | Tel: +91-22-42688700/ 91 / +91-22-66764491 /94 Fax: +91-22-66764495 E-mail: s7p19@vsnl.com, info@idealcures.co.in, Website: wwwidealcures.co.in Nameof the delegate: Mr. Jiten ShridharSurve Designation: Sr. Manager—Technical Company Profile: Ideal Cures is involved in pharmaceutical business for over 3 decades. Of those, | they have been specialized in the firm coating system | | arena for nearly a decade. The company has state-of art facilities located in Vasai near Mumbal and in Jammu in the state of Jammu & Kashmir in northern india. Gver the years Ideal Cures has remained dedicated to quality, research & development, sufficient capacity, CGMP and global regulatory requirements. Their manufacturing facilities are built to global standards. Ideal Cures is specialized in the field of Film Coating Systems. They develop, manufacture and supply INSTACOAT ready mix film coating system for the pharmaceuticals, Nutraceuticals, Veterinary, Herbal, Ayurvedic and Chinese Medicine. For more details please visit our web site www.idealcures.co.in INDO GULF COMPANY 101, Blue Bell Building, Sitaram Compound, Crawford Market, Mumbai~400001, India. JPN PHARMA PVT. LTD. 10/D, Matru Ashish, Near Balbharti School, S. V. Road, Kandivali (WW), Mumbat -400 067, India. Tel: +91-22-67141516/ 28643481 /28072182 Fax:+91-22-28640377 E-mail: info@jpnpharma.net Website: www jpnpharma.net Name ofthe delegate: Mr. ShahJayesh Popatlal Designation: Director ‘Company Profile: JPN Pharma Pvt. Ltd. is one of the largest Name of the delegate: Mr. Sayed Tanzil Ismail & Mr, manufacturer of Caproic Anhydride & Silver Sulphadiazine Shaikh M Shafique A Rahim _ having sophisticated plant ISO Indian GMP complaint WHO Designation: Export Manager & Business Analyst GMP by Dec 09 manufacture API's Alendronate Sodium Tel: +91-22-23455354/S5 / +91-22-23455220 Fax: +91-22-23476536 E-mail: info@indogulfgroup.com, indogulfco@gmail.com Website: www.indogulfgroup.com Ibandronate Sodium Pamidronate Disodium Risedronate Company Profile: An ISO 9001-2000 & WHO GMP Sodium Amlodipine Besylate Fosphenytoin Sodium | Certified Pharmaceuticals Finished Formulation & Bulk Bee ae ee “nig siniriere isacodyl Picosulfate Sodium Propyl Gallate Fluorescein Sodium Eosin Disodium Methylene Blue Drug Intermediate 4Aminobutyric Acid 3N methyipenthylamino propionic acid HCI Benzoin Benzilic Acid Heptancic Anhydride Gallic Acid Methyl Gallate, 2, 3, 4 Trimethoxy Benzaldenyde Schloro 4Amino 2, 1, 3 benzothiadiazole Ethylene Urea Acetyl Ethylene Urea Potassium Hydroxide Powder, Silver Nitrate Parabromo Aniline, 5-[4-[2-(5-Ethyl-2-Pyridyl) Ethoxy] pheny/] methylene-2-4thiazolidinedione. For more details please visit our web site www.indogulfgroup.com, For more details please visit our web site www.janpharma.net LABDHI PHARMACEUTICALS Unitno. 7, Natalwala Terrace, 53, Gokhale Road [South], LACTOSE (INDIA) LIMITED 211, Laxmi Plaza, Laxmi Industrial Estate, New Link Road, Dadar (W), Mumbai- 400028, India. ‘Andheri (W), Mumbai- 400053, India. Tel: 91 2266952701 / +9122 66952702/ 703 Tel: 491-22-66101752 Fax:+912266952704 Fax: #91-22-66101753 E-mail: lactose @vsnl.com,atul lactose @ gmail.com E-mail: labdhipharma@rediftmail.com, labdhipharma@grmail.com Nameof the delegate: Mr. Maheshwari Atul Designation: Executive Director Name of the delegate: Mr. Bharat Hargovind Shah Designation: Partner Company Profile: Lactose (India) is a WHO-cGMP | approved facility, having ISO 9000-2001 Certification as | “well as being granted Export House Status by Government of India. With up-to-date technology, the ‘company is one of the leading Producers & Exporters of Edible Lactose and Pharmaceuticals Grade Lactose. Apart from this, the company is also a contract loan licensing Manufacturing Exporter of liquid orals and tablets. Lactose (India) Limited is looking for Importer & Exporters of Pharmaceuticals Formulations and Dairy/Feod products. Company Profile: Labdhi Pharmaceuticals enjoys as imperious presence in the global pharmaceutical Industry today since 1981. The humble pride sprout as much from its cost efficientand quality products as from modestyand anethical value system. MACHEAL LABORATORIES LTD. 814, Devpath, B/HLal Bunglow, Off C.G. Road, Ahmedabad~380006, India. Tel: 491-79-26431236 /491-79-26430318 Fax: #91-79-26426672 E-mail: vipul.mohan@macheal.in Website: www.macheal.in Name of the delegate: Mr. Vipul Mohan Designation: Managing Director Company Profile: Macheal Laboratories Ltd. since inception (2003) stands different among many common. Name ofthe delegate: Mr. Gupta Ashutosh The company is into formulations of drugs & medicines. | ___ Designation: Executive Director MEDICAMEN ORGANICS LTD. 10, Community Centre #2, Ashok Vihar, Phase Il, Delhi-110052, India. Tel: #91-11-27463506/ +91-11-47589500 (30 lines) Fax:+91-11-27238171 E-mail: rsadhikari@medicamen.com Website: www.medicamen.com Macheal Labs Itd. already has an impressive and impeccable achievement of having their wings of Company Profile: Medicamen Organics Ltd. is one of the | success spread across the globe by maintaining and group company of Medicamen Group involve into | achieving global healthcare standard backed by manufacturing and exportation of pharmaceuticals contemporary marketing strategies. Their business | formulations in dosage forms ie. Tablets, Capsules, Dry objective is to achieve leadership in all possible key | | Syrups, Liquid Orals & Creams. MOL is having ultra- therapeutic areas. It is always their endeavour benefit modern plants, incorporating state-of-the-art for one & all. They assure you a complete range of | technology at Haridwar, Uttarakhand in India. After formulation under onesingle roof. successfully venturing to domestic merket, MOL now aggressively marching aheadinto Export market For more details please visit our web site www.macheal.in For more details please visit our web site www.medicamen.com | PHARMCHEM | PROTECH BIOSYSTEMS PVT. LTD. | 1568/8, Bhagirath Palace, New Delhi- 110006, India. 145-146, Sector-37, Pace City - I, Gurgaon, | Haryana 122 001, India. | Tel: 491-11-23536029 / +91-11-23536340 Tel: +91-124-4687000 Fax: #91-11-23554027 Fax: +91-124-4687007 E-mail: sanjiw@protechbiosystem.com, E-mail: phrmchem@hotmail.com sanjiw@gmail.com, ajay@protechbiosystem.com Website: www protechbiosystem.com Name of the delegate: Mr. Jain Nipun Name of the delegate: Dr. Sanjiw Kumar Singh Designation: CEO Designation: Chairman & Managing Director Company Profile: Pharmchem are WHO-GMP & ISO Company Profile: Protech Biosciences Pvt. Ltd. was | certified leading manufacturer of quality bulk drugsand | incorporated in 1998. Earlier it started manufacturing life saving medicines with an experience inthis Industry | _ the pharmaceuticals product on loan license in India and for more than 32 yrs. They are totally dedicated to | __ exported the same. Today, Protech Biosystems Pvt. Ltd. customer satisfaction. has its own manufacturing plant and is a manufacturer, distributor-cum-export house. The company operates in 12 states in India for its domestic salesbesides exports to Russia & CIS countries. The company delivers about 50 products for exports and domestic market. Thecompany has geined a reputation of a reliable supplier of health care products in India, Russiaand CIs countries. For more details please visit our web site ‘www.protechbiosystem.com R.L. FINE CHEM Ray House, # 2000, HIG, Next to Yelahanka, New Town, Police Station, Bangalore - 560 064, India. RAY CHEMICALS PVT.LTD. HIG 2000, Ray House, Yelahanka New Town, Bangalore- 560 106, India. Tel: +91-80-28561041 / +91-80-28561042 Fax: +91-80-28566630 E-mail: anjan@blrvsnlnet.in, rifinechem@eth.net Tel:+91-80-28561041 / +91-80-28561042 Fax:+91-80-28565630 _ E-mail: anjan@bicvsnl.net in, rifinechem@eth.net Name of the delegate: Mr. Mannappa Ramchandra Designation: Manager - Marketing Name ofthe delegate: Ms Trishna Roy Designation: Director Company Profile: R.L. Fine ChemisapartofRayGroupof | Company Profile: Ray Chemicals is a part of Ray Group of Companies. They are an USFDA approved, having COS, Companies. They are an USFDA approved, having COS, WHO-GIMP certified, manufacturing products as per ICH WHO-GMP certified, manufacturing products as per ICH | guidelines, Japanese Accredition obtained also having | __ guidelines, Japanese Accredition obtained also having | ISO 9001 certification. Their main products are ISO $001 certification. Their main products are Alprazolam, Amitriptyline, Imipramine, Clomipramine, Amitriptyline, Imipramine, Clomipramine, Doxylamine, Doxylamine, Succinate, Pitofenone, Fenpriverinium Succinate, Potofenone, Fenpriverinium Bromide, Bromide, Propiverine, Orphenadrine citrate, Propiverine, Orphenadrine citrate, Haloperidol, Haloperidol, Nortriptyline, Carbinoxamine Maleate, Loperamide, Nortriptyline, Carbinoxamine Maleate, Valethamate Bromide, Lorazepam, Pyrimethamine, Fuphanzine, Flupentixol, Melitracin, Flupenazine Temazepam, Trimipramine Maleate. hel/deconate, Valethamate Bromide, Pargevarine, Bromazepam, Clonazepam, Lorazepam, Alprazolam, Diazepam, Temazepam, Oxazepam, Phenazepam. SAHUL INDIA LTD. _ SG PHARMA PVT. LTD. | 26, Hemanta Basu Sarani, Mangalam 8, 542, 3/10, Bhuta Niwas, Dr. Ambedkar Road, Matunga Kolkata - 700 001, India (€), Mumbai-400019, India. | Tel: +91-33-22424159 / +91-33-22480533 Tel:#91-22-24152010 Fax: +91-22-24151565 E-mail: sahul@sahul.com, itsrashmi@gmail.com Website: www.sahul.com ‘Website: www sgoharma.com Name of the delegate: Ms Rashmi Singh Chauhan Nameof the delegate: Mr. Chetan Kiritkumar Bhagat Designation: GM - International Business Designation: Director Company Profile: Sahul India Ltd. is a GMP Certified | Company Profile: SGPharma Pvt. Lid.are the manufacturer company based in India. Sahul manufactures, markets | __of world-class life saving products (in WHO-GMP approved and exports pharmaceuticals and herbal cosmetics in | __ facilities) viz; Cardiovascular, Antibiotics, Neurological, India and abroad. Sahul believes in quality. The products | _ Anaesthetics, Anti-Microbials, Hormonal & Infertility, Ant manufactured under the Brand name “Sahul” have a _ Fungal, Anti-Cancer, Corticosteroids, Sclerosants. Many of huge demand in domestic as well as international ‘their products are niche and orphan drugs, which are markets. The manufacturing process complies SOP's as manufactured by very few companies/only the innovator. prescribed to maintain the standards and uniformity. | Their major Cardiovascular products are: Alprostadil Adeaunste; cual caniral. mescuras

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