| |
| .: CORPORATE QUALITY & REGULATORY : |
| |
Quality is a fundamental value that we
instill in all our employees, which
reinforces our commitment to our customers.
Our products pass through stringent tests
backed by quality systems that ensure
compliance with international standards. |
| |
|
Quality Organization |
Corporate Quality & Regulatory Affairs is an independent function and directly reports to Chairman & Managing Directior of the company. Sections like Quality Assurance, Quality Control, Quality
Engineering,Regulatory Affairs, Stability studies, Corporate QA and Bio-Equivalence studies are under one roof. |
| |
|
Total Control |
|
We have capabilities in both hardware and
software in developing and standardising
analytical techniques for all our products.
In addition to that, we support research
endeavours of the company. |
| |
|
Quality Appearance |
|
Quality assurance is dynamically structured
in line with international markets. We are
acquiring and developing the requisite
skills and expertise to strengthen in-house
skills through extensive training and
multiple technical audits. |
| |
|
Advanced Engineering |
|
We have designed and introduced the concept
of Qualification and Validation to provide
the best value proposition to our global
customers. |
| |
|
Regulatory Affairs |
|
We possess capabilities for preparing
ANDA in eCTD , Technical Dossiers and Drug Master Files (DMFs)
for a range of our products. Our facilities
are constantly upgraded to comply with
European and US Regulatory inspections,
making us strategically poised to enter the
regulated markets.Our facilities have been successfully audited by US-FDA and European Agencies. We have filed and received approval of some of our ANDAs and COS from respective Regulatory agencies. |
Regulatory Filings by Alembic Limited
| Cumulative US DMFs filed |
36
|
| Cumulative ANDA Filed |
22 |
| Cumulative CoS Filed |
12 |
| ANDA Approval Received |
07 |
Finished Dosage Form Facility has been Audited and Approved by
- US-FDA
- MHRA (2 Times)
- TPD (Canada)
- MCC (South Africa)
API Facility has been Audited and Approved by
- US-FDA ( 2 Times)
- EDQM ( 2 Times)
- TGA (Australia)
- German FDA
- KFDA
|
| |
| |
|
Our Technical Expertise covers
the following areas below: |
| |
|
Acetylation |
Acylation |
Alkoxylation |
|
Alkylation |
Fenofibrate |
Amination |
|
Beckmans rearrangement |
Chloro methylation |
Chlorosulfonation |
|
Condensation |
Cyclization |
De carboxylation |
|
De Halogenation |
De hydrogenation |
Diazotization |
|
Epoxidation |
Esterification |
Ethoxylation |
|
Freidelcraft Reaction |
Grignard Reaction |
Halogenation |
|
Isomerisation |
Methylation |
Nitration |
|
Oxidation |
Oximation |
Phase transfer reduction |
|
Phosgenation |
Reduction |
Sandmeyer reaction |
|
Saponification |
Silylation |
Tosylation |
| |
|
Peculiar Technologies: |
|
|
| |
|
Extraction from Botanicals |
Fermentation |
Powder processing |
|
Enzymatic reactions |
Spray drying |
Fluid bed drying |
|
Lypholization |
|
|
|
| |
|
|
| |