Gonoshasthaya Antibiotics Limited
Gonoshasthaya Antibiotic Limited (GAL) is the pioneer in manufacturing basic active ingredients in Bangladesh, which are used by pharmaceutical formulation plants all over the country. GAL originally started in 1984 as a division (Antibiotic Division) of GPL to produce basic raw materials and bulk antibiotics for the first time in Bangladesh. Later on, GAL emerged as another limited company under the umbrella of Gonasthasthaya Kendra, a public charitable trust.
Objectives
of GAL Unit 1 |
To produce raw materials and bulk drugs.
To keep abreast the latest discoveries, inventions, innovations and technologies
through technology transfer.
To help the nation to be self dependent in all stages of drug manufacturing,
from basic active ingredients for Antibiotic to finished products.
| GAL
Unit 1 at a Glance |
Year of Production . : 1984
Location of Factory : Near National Mausoleum at Savar, Dhaka-1344, Bangladesh.
Work Force ...........: 150
Production Capacity
per Annum ............ : 150 Metric Ton basic ingredients
for Antibiotics
Plant Area ............ : 250,000 Sq-ft
Gonoshasthaya Antibiotics Limited Care for People and Quality |
 |
Tests and checks made of the procured basic chemicals and Packing materials to the final marketing of bulk Antibiotics are as follows :
| Before Production |
| Characteristics
Water Content pH Values Specific Optical Rotation Clarity of Solution Identification - IR Absorption - Optical Rotation - UV Absorption - GLC - Specific Reaction Assay - Iodometric Titration - Potentiometric Titration - GLC - HPLC - Flame Photometry - UV and Visible Spectrophotometer |
Solubility Acidity Limit Test for Sulphate Light Absorption TLC Arsenic Chloride Neutralising Capacity Viable Count Alkalinity Melting Point Boiling Point Specific Gravity Heavy Metals Refractive Index |
| During Production |
| Water
Purification De-Mineralization Distillation Humidity Control Temperature Control pH Control Assay |
Batch
Number In-process Checks Colour Specific Gravity Machine Cleaning Checkup Expiry Date Manufacturing Date |
| After Production |
| Neatness
and Cleanliness Batch Number Manufacturing Date |
Fibre
Drum Packing Carton Packing Expiry Date |
Quality of Pharmaceutical Raw Materials : GAL remains within the specification level of British Pharmacopoeia (BP), United States Pharmacopoeia/National Formulary (USP/NF), European Pharmacopoeia (EP) and International Pharmacopoeia (IP). GAL follows the guidelines of Good Manufacturing Practice (GMP), Good Laboratory Practice and Good House Keeping Practice.
Research,
Development and Quality Assurance: This department runs with qualified
and experienced personnel, modern machinery and equipment. It follows latest
methods to keep up the standards of the products and production.
This department continuously works for development of new Pharmaceutical Raw
Materials and improvement of existing ones.
Accomplishment
of GAL in Research
In early 90s, as the Antibiotic Division of Gonoshasthaya Pharmaceuticals Limited,
GAL personnel carried out a research on detailed pharmaceutical analysis and
the stability-testing of locally manufactured Ampicillin Trihydrate. Generally
these information are not included in BP, USP or any other pharmacopoeias. Studies
showed the presence of traces of Ampicillin polymers and hydrolysed products
in accordance with international reference standard.
However, it was found that the presence of certain chemicals has tremendous
effect on the stability of product simple accelerated stability-testing method
was established in comparison with the products of world's leading manufacturers.
Present
Bulk Drugs
1. Amoxycillin Trihydrate BP/USP (Compacted/Micronised)
2. Ampicillin Trihydrate BP/USP (Compacted/Micronised)
3. Cephalexin Monohydrate BP (Compacted/Micronised)
4. Cloxacillin Sodium BP/USP (Compacted/Micronised)
5. Flucloxacillin BP/USP (Compacted/Micronised)
| Future
Bulk Drugs 1. Azithromycin Dihydrate USP 2. Nevirapine - BNF - 43 (MAR 2002) 3. Cephradine BP 4. Ciprofloxacin HCl, H20 BP |
  |
Gonoshasthaya
Antibiotics Limited-Unit 2
Gonoshasthaya Kendra Trust believes that a developing country like Bangladesh
which has got a large population should be self-reliant in the production of
Basic active ingredients of bulk drugs and Finished products of medicines as
well.
S. Mujibullah (Alkaloid) Sons Limited started business in early fifties with
exporting monkey to John Hopkins University, USA for research. In 1978 S. Mujibullah
(Alkaloid) Sons Limited became Pharmachemy (BD) Limited.
In 1966, the plant went in to production of natural Alkaloids, Alkaloidal derivatives,
Herbal Extracts, and Herbal Resin. And exported scopolamind HBr and Phodophyllum
Resin.
In 1990, Gonoshasthaya Antibiotics Limited started GAL Unit 2, a new division
called Gonoshasthaya Antibiotic Limited (Chemical Division) by buying off Pharmachemy
(BD) Limited for producing basic active ingredients for medicines other than
Antibiotic.
Objectives
of GAL Unit 2
To help drug manufacturers (finished goods) by providing Basic Active Ingredients
for medicines other than Antibiotic at reasonable price.
To manufacture quality Basic Active Ingredients which will work as import substitutes
and thereby save Foreign Exchange.
GAL
Unit 2 (Chemical Division) at a Glance
Year of Production : 1966
Location of Factory : Tongi Industrial Area, Tongi, Gazipur, Bangladesh.
Manpower : 50
Production Capacity
per Annum : Paracetamol BP / USP - 200 Metric Ton
Diclofenac Sodium BP - 15 Metric Ton
Diclofenac Potassium BP - 10 Metric Ton
Plant Area : 170,000 Sq-ft
Products
of GAL Unit 2
Basic Active Ingredients for Medicines other than Antibiotic
Paracetamol BP/USP
Diclofenac Sodium BP
Diclofenac Potssium BP