Shilpa Medicare Limited has announced the receipt of the Good Manufacturing Practice (GMP) Certification for its Unit VII in Nacharam, Hyderabad, from the European Medicines Agency (EMA), Austria. This certification follows a successful inspection conducted from September 24 to September 26, 2024.
The Unit VII facility includes an Analytical Services Division (Quality Control) and a Bio-Analytical Department, both of which are already approved by the USFDA. This marks the first European inspection for the unit’s QC laboratory, which is responsible for testing drug substances, raw materials, packaging materials, and finished products. The facility also handles analytical activities such as method validation and method transfers, ensuring product release for markets in the US, EU, and other regions.
About Shilpa Medicare
Shilpa Medicare is a leading pharmaceutical group specializing in niche Oncology and Non-Oncology APIs, peptides, polymers, and advanced finished dosage formulations such as orally dispersible films and transdermal patches. It also has a robust biological portfolio and offers comprehensive CDMO services. With four R&D units and seven manufacturing facilities, Shilpa is committed to innovation and quality in its pharmaceutical solutions.
The GMP certification reinforces Shilpa Medicare’s commitment to maintaining the highest quality standards in its global operations.
