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.: 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
 
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