Orchev Pharma Pvt. Ltd.

AN ISO 9001:2008 COMPANY

Orchev Pharma Pvt. Ltd. established in 1989 as

a single site operation, Orchev has a reputation
for manufacturing Ranitidine Hydrochloride as
per latest USP/EP/BP/IP. Its growth has been
fuelled by relationships with global market
participants that want to conduct business with
a company that maintains high levels of quality.

Since beginning of operations in 1989, Orchev

Pharma Pvt. Ltd. has quickly emerged as a
leading manufacturer of high quality of
pharmaceutical raw material i.e. RANITIDINE
HYDROCHLORIDE in the Gujarat State of India.
What separates Orchev from other trusted
manufacturers is not only that we manufacture
excellent quality Ranitidine Hydrochloride of
various grades; provide excellent services to
customers, which additionally includes small
scale manufacture of product for trial supply
and full scale manufacture for commercial
supply. Orchev employ chemist, chemical
engineers, microbiologist of highest caliber and
maintain the quality assurance standard.

With our proven experience and expertise;

Orchev manufactures under (fully complies with)
the standards of WHO � GMP, FDA INDIA. We
have received Certificate of Suitability (COS)
from EDQM with CEP number - CEP-320-2007
Rev 00. We have been audited & Approved by
Korean Food and Drug Administration (KFDA)
and COFEPRIS - Mexican Health Authoriy.
Orchev Pharma Pvt. Ltd. is an ISO 9001:2008
company.
Active Pharmaceutical Ingredients
Ranitidine Hydrochloride - USP/EP/BP/IP in
different grades
DC Grade - PS 30# granules, Tapped density
range 0.65 to 0.85 gm/cc *
Crystalline Powder - PS 80#, Tapped density
0.45 to 0.65 gm/cc *
Injection Grade - Absorbance, 10% Aqs Soln, at
430 nm; NMT 0.05 *
�� All Grades of Ranitidine we produce are
free from MIBK and Toluene.
(*) indicates Customers Requirement if any / In-
House Limits can be manufactured.

Active Ingredients
Ranitidine BASE
NMSM
Cystophur

Products
sodium methyl mercaptide - CAS # 5188-07-8
Sodium thiomethoxide - CAS No. 5188-07-8
Sodium methylthiolate - CAS # 5188-07-8
Methyl Mercaptan Sodium Salt - CAS # 5188-07
-8

ORCHEV welcomes queries from manufacturer,

importers, exporters and all other related
directly or indirectly to our product or services
from India and Abroad.
OFFICE

Orchev Pharma Pvt. Ltd.

Rangoli, Gondal Road
Rajkot - 360 002
Gujarat – India
Phone: +91 281-
2365731 / 2365732
Fax: +91 281 – 2365733
Email: info@orchev.com

FACTORY
Orchev Pharma Pvt. Ltd.
Shapar Industrial Area,
Rajkot - Gondal Highway
Veraval
District - Rajkot - 360 024
Gujarat - India

Phone: +91 2827 - 252114 / 252115

Fax: +91 2827 - 252113

career
ORCHEV is a unique and exciting place to
begin, advance, and elevate your career. We
offer a high-energy atmosphere that
features a team-oriented environment and
unlimited growth potential. Add flexible
working hours and regular company-
sponsored social events, and it almost
doesn't feel like work!

As a member of ORCHEV, you will have the

opportunity to thrive in this challenging and
fast-paced environment. Plus, we offer
competitive salaries. It all adds up to an
employment package that will make you
want to join not only for where the company
is today, but also for where it's heading
tomorrow.

Now is the time, and this is the place. If you

want to join ORCHEV team, contact us
today at. careers@Orchev.com

Export

With high competitive players in the

international arena, exporting the
product was indeed a challenge for
ORCHEV. Though the product has been
made suitable to access every market
and fulfill all the requirements of foreign
associates, still there existed a need to
gain a competitive edge in developing
the export market. At present ORCHEV
is exporting 60 to 70% of its final output
to foreign markets.
Quality

Ranitidine-HCl Quality

(A) Ranitidine Hydrochloride

manufactured have following unique
characteristics :

1) Better whiteness (Abs C 0.1)

2) Low toxicity (Ranitidine free from
MIBK & Toluene)
3) High Stability (Shelf life of 5 years)
4) Physical properties (Available as
required by the end user)

(B) Regular Grades of Ranitidine

Hydrochloride manufactured:

1) Crystalline Powder (80#, Tap density

0.45 to 0.65 gm/ml)
2) DC Grade Granular Powder (30#, Tap
density 0.65 to 0.85)

(C) Available in the following

pharmacopeia:
1) USP 34
2) EP 7.0
3) BP 2011
4) IP 2007

(D) Regulatory approvals available:

1) WHO – GMP
2) EDQM - COS (CEP 2007 / 320)
3) Korean Food and Drug Administration
(KFDA)
4) COFEPRIS - Mexican Health Authority
5) Written Confirmation for EU
6) Ranitidine registered with RUSSIAN -
State registration of medicinal products
7) ISO 9001:2008 issued by TUV SUD
8) DMF filed with TPD - Canada

(E) Plant compliant with:

1) USFDA
2) ICH Q7 GMP

QUALITY CONTROL &

QUALITY ASSURANCE
ORCHEV performs a promising growth
through its separate state-of-the-art
Quality Control Department, the systems
and activities of different departments,
conducts internal audits and training
programme. It assures the quality of the
product dispatched from the
manufacturing activities. The QC
department has been clearly instructed
to make no compromise whatsoever,
either in the procurement of raw
materials, or in the final output. Besides,
QC Department not just informs about
the specifications of the product, but
also provides valuable contribution in
enabling production of high quality
product with maximum yield.
The QA department is proficient in all
the aspects of system designing and
maintenance needed for a cGMP facility.

The QA/QC team is lead by a group of

talented professionals.

Facilities
Regulatory Approvals

Orchev Pharma Pvt. Ltd. is involved in

the process of manufacturing quality
Ranitidine Hydrochloride in
accordance with GMP, USFDA and
ICH Q7 guidelines. Our plant located
at Rajkot is manufacturing only one
API, i.e., Ranitidine Hydrochloride.
The plant has following regulatory
approvals:
1) WHO – GMP
2) EDQM - COS (CEP 2007 / 320)
3) Korean Food and Drug
Administration (KFDA)
4) COFEPRIS - Mexican Health
Authority
5) Written Confirmation for EU
6) Ranitidine registered with
RUSSIAN - State registration of
medicinal products

7) ISO 9001:2008 issued by TUV SUD

8) DMF filed with TPD - Canada
Production

The facility spread over an area of

16187 sq.m with 3966.46 sq.m built
up area. Production of Ranitidine is a
very high lengthy process. At each
stage, utmost care is taken to ensure
perfect quality. The production unit is
equipped with S.S. 316 Reactors
ranging from 500 to 6000 Ltrs.
capacity, Glass line Vessels ranging
from 500 to 3000 ltrs capacity, S.S.
316 Centrifuges, S.S. 316 Sparkler
filters, S.S. 316 Roto Cone Vacuum
Dryers and S.S. 316 Distillation
Columns. The Production
Department functions with team of
qualified Chemical Engineers.

Powder processing Area

Crystallization of Ranitidine HCI is
carried out in clean room facilities
(PHARMA AREA) equipped with GMP
model Glass line reactors & GMP
model 4P centrifuges. HVAC System
is installed to maintain class 10000
(0.3 micron HEPA) in PHARMA AREA.

Packing and Storage

Ranitidine HCI being highly
hygroscopic in nature has to be
handled with utmost care. Our
powder processing area is under
controlled environment class 10000
(0.3 micron HEPA). Our powder
processing department is equipped
with Roll Compacter, Shifter,
Granulator, and Octagonal Blender.

Utility
The production facility is helped by
Utility Department having fully
automatic steam boiler, chilling
plants, Cooling towers, Water
softeners, Nitrogen plant, R.O. Plant,
D.G. Set, Dust Collection System and
HVAC System.

Pollution Control
ORCHEV respects the environment
and takes every possible steps to
protect it. The whole plant is in
retention for the liquid raw materials
arrival as well as for the departure of
the liquid wastes. We have, to our
credit, an effluent treatment plant
(ETP), one of the largest of its kind in
Western Gujarat. Stringent measures
are adopted to ensure that the
parameters affecting pollution are
quite within the norms laid down by
the regulatory bodies. Solid waste is
sent for processing and disposal to
approved contractors, while the
factory has the necessary equipment
to treat and or retreat discharge of
atmospheric release. We are
developing Green Belt Area in the
60% of total land of unit to minimize
the Pollution.
 Project at Glance:-
1. Name of Unit ORCHEV PHARMA
2. Registered Address Orchev pharma, Rangoli,
(Office) Gondal Road, Rajkot-
360002,Gujarat India.
Phone:- +91 281- 2365731
/2365732
Fax :-+91 281- 2365733
Email:- info@orchev.com
3. Factory Location ORCHEV PHARMA PVT.LTD.
Shapar Industrial Area,
Rajkot – Gondal Highway
Veraval
.Distric:- Rajkot-360024.
Gujarat, India.
4. Form of Partnership Firm
Organization
5. Name of CHAIRMAN Mr. Vasasnt Bhalodia
6. Product RANITIDINE HYDROCHLORIDE