Quality Systems/ Quality Control
In our manufacturing facilities, the underlying principle of product manufacturing is based on the concept of quality by design. The key aspects such as vendor management, critical control measures which are essential for robust manufacturing is monitored by competent and experienced professional team. The in-house lab is adequately equipped to perform routine tests for release of KSM, RM, in-process and finished product as per the pharmacopeial standards. The overall GWP, GMP & GLP environment allows us to produce and deliver quality goods to our esteemed customers.
For our trading business, the QA team ensures Good Warehouse Practise (GWP) for material management, storage and distribution at our dedicated warehouse located at Chennai in accordance with the Drugs Control Department guidelines and in-house Standard Operating Procedures. Our QMS (Quality Management Systems) meets the requirement of ISO 9001:2015 certification.
The QC & QA team regularly visit Contract Manufacturing Units (CMUs) for process & product documentation review. QC teams also visit customers laboratories for analytical method demonstration/method transfer activities. We engage with various NABL-accredited, well-equipped reputed laboratories for performing speciality tests so that we can meet the additional customer specifications.
Regulatory Compliance
We understand the regulatory requirements for registration of Drug Substances with Central Drugs Standard Control Organization (CDSCO) - National Regulatory Authority of India. We have successfully registered over 20 APIs offered by various world-class manufacturers with USFDA/EUGMP certifications.
We also offer Drug Master Files (DMFs) of speciality APIs from our CMUs as well as own-sites. Our APIs are registered in various geographies comprising of South America, CIS, SE Asia and Middle East.
It has been our constant endeavour to work with Global pharma Companies & Emerging pharma Companies in India and International markets to meet their expectations on products and services.