Quality system designed to meet global standards
Our quality system is designed to meet the most stringent global regulatory standards. This enables us deliver products that consistently meet the expectations of the markets we serve, particularly US, EU and Japan.
We ensure quality through a robust governance framework encompassing our facilities, people, procedures, and our value system that emphasises on integrity and continuous improvement.
GMP for commercial products
Our quality system is designed in adherence with USFDA, EU, TGA and ICH guidelines, 21 CFR Part 210 and 211 and Indian cGMP standards (Schedule M), for manufacturing registered intermediates and commercial APIs.
Phase-appropriate GMP
During the development phase of a molecule, the process and test procedures for manufacture of intermediates and APIs need to be flexible. We have established quality principles that are phase-appropriate and comprehensive for the manufacture of molecules with robust scientific methodology.
Quality System Design
Designed to meet global quality standards for various stages of drug development and final APIs (NCEs/Generics) with key inputs from:
- FDA Guidelines on Drug Development and Characterization
- 21 CFR Part 210 and 211
- 21CFR Part 11 and Annex-11
- EMEA – cGMPs for human drug products (EC/2003/94)
- TGA guidelines on quality
- ICH guidelines on Quality (ICH Q1 to Q11)
- Indian cGMP standards (Schedule M)
Regulatory approvals
- R&D centre, Hyderabad, India
Approved by USFDA
GMP certified by regional regulatory bodies in India - Manufacturing facility, Hyderabad, India
Registered with USFDA
GMP certified by regional regulatory bodies in India - Manufacturing facility, Bidar, India
Approved by USFDA
Approved by PMDA, Japan
Approved by COFEPRIS, Mexico
Certificate of Pharmaceutical Product (WHO)
Written Confirmation from EU GMP
GMP certified by regional regulatory bodies in India - 75+ successful customer audits in the past three financial years