Granules India Jeedimetla facility bags accreditation certificate of Foreign Drug Manufacturer from PMDA
Hyderabad: Granules India Limited has announced that the company has received the Accreditation Certificate of Foreign Drug Manufacturer from Pharmaceuticals and Medical Devices Agency (PMDA), Japan for its Jeedimetla facility, located at Jeedimetla, Quthbullapur Mandal, MedchalMalkajgiri District, Hyderabad, Telangana.
The certification has been received for accreditation categories of non-sterile Drugs, Packaging, Labelling and Storage of Drugs. Jeedimetla facility manufactures Active Pharmaceutical Ingredients (API) and Pharmaceutical Formulation Intermediates (PFIs).
Read also: USFDA nod to Granules India Metoprolol Succinate ER Tablets
Medical Dialogues team had earlier reported that the Company’s Jeedimetla facility located at Hyderabad, Telangana, India had successfully completed the US FDA’s surveillance inspection with zero (0) 483 observations.
Read also: USFDA successfully concludes inspection at Granules India Jeedimetla facility
Granules India Limited, incorporated in 1991 is a vertically integrated Indian pharmaceutical company headquartered at Hyderabad. The company is among the few pharmaceutical companies in the world to be present in the manufacturing of entire value chain – from Active Pharmaceutical Ingredients (APIs), Pharmaceutical Formulation Intermediates (PFIs) and Finished Dosages (FDs). Its products are being distributed to over 300+ customers in regulated and semi-regulated markets with a global presence extending to over 80+ countries with offices across India, U.S. and U.K. The Company has 8 manufacturing facilities out of which 6 are located in India and 2 are in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL.
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