Undergraduate Industrial Training

FDC INDIA
(Research & Development)
Training period:-14.02.2011 – 31.03.2011
Report for the term 14.02.2011 -19.02.2011

Ms. Gunjan S. Patel

Roll No.:- 41
 FDC
FDC (Foods,
Drugs &
Chemicals)
formerly known
as Fair Deal
Corporation, has
been in the
pharmaceutical
business for
more than seven
decades now.
 History Of FDC

1936:-With a modest beginning in 1936 – marketing vitamins and a

range of prescription formulations - FDC set up its first formulations
manufacturing facility in 1949.

1963:-Subsequently, in 1963, FDC pioneered the manufacture of

specialized ophthalmic formulations in India.FDC was the first
organization to introduce the BFS (BLOW-FILL-SEAL) technology
for ophthalmics in South East Asia.

1972:-In 1972, FDC initiated the concept of Oral Rehydration Salts

(ORS). Today its pioneer brand 'Electral', stands apart with a special
identity- an impressive achievement in a fiercely competitive market.

1984:-FDC's API plant at Roha (Maharashtra) was among the first

few API facilities in India to get US-FDA approval in 1984. Since
then, FDC has to its credit a number of new molecules, introduced for
the first time in the nation.
 Achievements
 2008:- * Received US FDA nod for two
ophthalmic products
 2002:- * First UK-MHRA approval for
 * USFDA approval received for Waluj oral solids facility at Goa
without any observations (No 483's)

 1999:- * Formed a JV in UK
 2007:- * MHRA approval received for
Goa- I
 1998:- * UK-MHRA approval for
 * MHRA reapproval received for Waluj
ophthalmic facility at Waluj

 2006:- * Forbes rates FDC as the "BEST

UNDER A BILLION COMPANIES"
 2005:- * First US-FDA approval for
ophthalmic facility at Waluj
 * Filed 2 ANDAs for ophthalmic dosage
forms in the U.S.
 1996:- * Public issue of 26, 28, 200
equity shares of Rs. 10 each at a premium
of Rs. 90 each
 * FDC awarded 'Export House' status
 * FDC established a specialized &
dedicated field force to promote its
ophthalmic specialties

 2004:- * JV in the UK converted to a

Wholly Owned Subsidiary
 * Established JV in South Africa
 Achievements
 1994:- * FDC became the first company in
India to introduce ophthalmics in blow-
fill-seal packs, which optimize sterility
and are highly user friendly
 1984:- * Foods division set up for
manufacture of specialized infant foods
at Roha

 1977:- * Active Pharmaceutical

 1992:- * National Award from the Council Ingredient (API) plant commissioned at
of Scientific Research and Industry for Roha, Maharashtra
Indigenous R&D of Flurbiprofen and
Timolol

 1974:- * FairDeal's R&D facilities obtain

recognition from the Govt. of India
 1991:- * Biotechnology research center
set up at Waluj.

 * Started production of Timolol

Maleate (API).

 1972:- * Electral introduced by FairDeal –

a result of pioneering work in rehydration
 Locations Of Plants
Besides being successful in marketing its wide range of
products in the domestic market, FDC also exports many
of these products to Canada, USA, UK, Europe, Japan and
several countries in the Middle East, Asia and Africa.

The company has the most modern manufacturing

facilities at Mumbai, Waluj (UK-MHRA approved) ,
Roha(US-FDA and WHO-GMP certified ) , Sinnar(a
technologically advanced and a high capacity plant for
ORS-Oral Rehydration Salts) and Goa (UK-MHRA
approved) .
 Products Manufactured
Anti Fungal/Dermatological ENT and Related
Anti-Anaemic Genito Urinary Syatem & Sex
Hormones
Anti-Diabetic
Laxatives
Anti-
Diarrhoeals/Intetinals/ORS Musculo-Skeletal System
Anti-Haemorrhagics Opthalmics
Anti-Oxidants Orthopaedics
Anti-Spasmodics Otologicals
Antibiotics/Antibacterials Pre-Probiotics
Antiemetics/Antinauseatic Respiratory & Antiallergic
Antivirals Stomatologicals
Antimalarials Vitamins &Nutraceuticals
Antiulcerants
Calcium Supplements
 Organogram of Research &
Development Department

Research & Development Department

(Analytical)

ARDL- ARDL- ARDL-

I II III

Method Validati Semi- Regula Stabilit ANDA Stabilit

Domest Third
Develo on & regulat tory y y Party Sampl
pment ic Technol ory Market Studie e
Sampl
(Semi- ogy Querie s e Analysi
regulat Transfer s& Analysi s from
ory & Validat s or Locatio
Domes ion Loan n
tic License
Market
)
 Brief Introduction
• I have been placed under ARDL-I Department.
• Mr. Rajesh N. Mali is the Manager of this department.
• In this department the various sub-units are;
• Method Development (Semi-Regulatory & Domestic Market)
• Domestic Department
• Validation & Technology Transfer
• Semi-Regulatory queries & Validation.

I was in the Method Development Department whose Group Leader is Dr.

Gunesh Gundi.
The Group Leader of Domestic Department is Mr. Pravin Botre.
The Group Leader of Validation & Technology Transfer id Mr. Sarvesh
Bane.
The Group Leader of Semi-Regulatory queries & Validation is Mr. Avadhoot
Supal.

In the Method Development Department, the various analytical methods for

specific durgs which are manufactured are developed.
These include Assays, Dissolution ,Related Substance, pH, Identification
tests, etc.
 14th February, 2011.

On 14.02.2011, I met the HR. He took me to the ARDL-I (Analytical

Research & Development Laboratory-I) and there I met Mr. Rajesh Mali who is
the manager of the department.
Mr. Rajesh Mali introduced me to the whole department employees and
further from there Dr. Gunesh Gundi guided me.
Dr. Gunesh Gundi gave me a detailed information on how their group worked
on the development of the methods and all other units in that department.
Thereafter I was given SOPs (Standard Operating Procedure) of all the
instruments which were used in the laboratory and I read all of them the whole
day.
 14th February, 2011 contd…
List of SOPs read:-
• Use of Standard Units & Abbreviations.
• Stability Test Chamber.
• Operation & Cleaning of Lab Refrigerator.
• Magnetic Stirrer.
• pH Meter.
• Milli-Q water purification system.
• Dissolution Tester.
• HPLC.
• Analytical Balance.
• Gas Chromatography.
• Ultrasonic Bath.
Chromatography
 15th February, 2011
On 15th February, I was with Mr. Sachin. He gave me a brief introduction of
the working of the HPLC instrument.
We performed and experiment to develop assay ethod for the
preservatives used in Azapentacene Eye Drops.
Preservatives :
• Methyl Paraben
• Propyl Paraben
• Thiomersal

HPLC
• Principle of HPLC:-
High Perforamnce Liquid Chromatography is a chromatographic technique that
can separate a mixture of compounds is used in biochemistry and analytical
chemistry to identify, quantify and purify the individual components of the mixture.
• Difference between Normal Phase and Reverse Phase Chromatography:-
Normal Phase Chromatography separates analytes based on polarity, it has a
polar stationary phase and a non-polar mobile phase.
Reverse Phase Chromatography separates analytes using a non-polar stationary
phase and a moderately polar mobile phase.
 15th February, 2011 cont…
• Different Parts of HPLC:-

• Mobile Phase / Solvent Reservoir

• Degasser
• Solvent Delivery System (Pump)
• Injector
• Precolumn
• Column
• Temperature Control
• Detectors
• Recorder (Data Collection)
 HPLC Basic Instrumentation
1. HPLC

Solvent Delivery Detector

Injector
Column

Separation
Mobile Pump
phase

Sample Injection

Data Processor
 16th February, 2011
On 16th February I performed TLC. We were
identifying Rose Oil from MOISAL Eye Drops.

TLC
• Principle:
The Principle is based on ADSORPTION
Chromatography
The component with more affinity towards the
stationary phase travels slower.
The component with lesser affinity towards the
stationary phase travels faster.
 Stationary phase
NAME COMPOSITION
Silica gel H Silica gel without binder
Silica gel G Silica gel + CaSO4
Silica gel GF Silica gel + Binder + fluorescent indicator
Alumina Al203 Without Binder
Al203 G Al203 + Binder
Cellulose powder Cellulose Without Binder
Cellulose powder Cellulose With Binder
Kieselguhr G Diatomaceous earth + binder
Polyamide powder Polyamide
Fuller’s earth Hydrous magnesium alumina
Magnesium Silicate magnesol
 Mobile phase
1) Nature of the substance to be separated i e weather it
is polar or non-polar.
2) Mode of Chromatography.
3) Nature of Stationary phase.
4) Mode Separation i e Analytical or Preparative.

Examples: 1) Petroliam ether 2) Cyclohexane

3) Acetone 4) Toluene
5) Ethyl acetate 6) Benzene
7) Alcohols 8) Water
9) Chloroform 10) Pyridine
 Application of sample
The concentration of the sample should be 2--5µl of a 1% solution.

Sample is spotted using a capillary tube or micropipette.

Spots can be placed at random process .

Spots should be kept atleast 2cm above the base of the plate.

Spotting area should not be immersed in the Mobile phase.

Go for development.
 Development tank
The development tank

should be lined Inside

with filter paper moistened

with mobile phase to

saturate the atmosphere

& also prevent the

“ EDGE EFFECT ” .
 Detecting agents
Detecting agents are two types. they
are,
(A)Non-Specific method
1) Iodine chamber method.
2) Sulphuric acid spray method.
3) UV chamber for fluorescent
compounds.
4) Using fluorescent stationary phase.
(B) Specific method
1) Ferric chloride.
2) Ninhydrine in acetone.
3) Dregendroff reagent.
4) 3,5 – Dinitro benzoic acid.
5) 2,4 - Dinitro phenyl hydrazine.
 detection
The Rf value is calculated for
identification "Rf value is the
ratio of distance travelled by
The solute to the distance
travelled by the solvent front”

Distance travelled by solute

Rf =
Distance travelled by solvent front
Comparison of tlc & hplc
 17th, 18th &19th February,
2011

• On all these 3 days I worked alongwith Mr. Sachin to

develop the Assay method for Nizi tablet.
• Label Claim:
Each uncoated tablet contains:
Nimesulide-100mg
Tizanidine HCl equivalent to Tizanidine-20mg.
Nimesulide
 Nimesulide
 Nimesulide is a relatively COX-2 selective, non-steroidal anti-
inflammatory drug (NSAID) with analgesic and antipyretic properties.
Its approved indications are the treatment of acute pain, the
symptomatic treatment of osteoarthritis and primary dysmenorrhoea
in adolescents and adults above 12 years old. Due to concerns about
the risk of hepatotoxicity, Nimesulide has been withdrawn from
market in many countries
 Central Drugs Standard Control Organization of India bans
Nimesulide
 Several reports have been made of adverse drug reactions in India .
On Feb 12, 2011, Express India reported that the Union Ministry of
Health and Family Welfare had finally decided to ban the paediatric
use of the analgesic, Nimesulide suspension. A notification to this
effect was expected soon, following which the drug would be off the
shelves
Tizanidine
 Tizanidine cont…
• Tizanidine has been found to be as effective as other antispasmodic drugs
and have superior tolerability than baclofen and diazepam.[2] Tizanidine
may cause hypotension, so caution is advised when it is used in patients who
have a history of orthostatic hypotension. Use caution with this drug as it
can be very strong even at the 2 mg dose. Also use caution when switching
from gel cap to tablet form and vice versa.
• Tizanidine can occasionally cause liver damage, generally the hepatocellular
type. Clinical trials show that up to 5% of patients treated with tizanidine
had elevated liver function test values, though symptoms disappeared upon
withdrawal of the drug. Care should be used when first beginning
treatment with tizanidine with regular liver tests for the first 6 months of
treatment.
• The tablets are composed of the active ingredient, tizanidine
hydrochloride (2.288 mg equivalent to 2 mg tizanidine base and 4.576 mg
equivalent to 4 mg tizanidine base), and the inactive ingredients, silicon
dioxide colloidal, stearic acid, microcrystalline cellulose and anhydrous
lactose.
 The method development for Nizi tablets was by HPLC
Method.
 The method is yet not developed and is still under
development.
Thank You