Shilpa Pharma Lifesciences Unit II Raichur facility clears PMDA Japan GMP inspection
Karnataka: Shilpa Medicare Limited has announced that PMDA, Japan has successfully concluded GMP inspection without any critical/major observation at the company's 100% subsidiary, Shilpa Pharma Lifesciences Limited’s Active Pharmaceutical Ingredient (API) manufacturing facility, Unit II, situated at Raichur in Karnataka state.
The facility has undergone an inspection by PMDA, Japan starting 29th August 2023.
"The inspection has concluded successfully on 1st September 2023 without any critical/major observation," the company stated in a BSE filing. The facility is involved in manufacturing various oncology and non‐oncology APIs.
"The company remains committed to maintain the GMP status and quality standards as per the expectations and standards of Global Regulatory Authorities," Shilpa Medicare stated.
Read also: Shilpa Medicare Raichur facility gets Russian GMP certificate
Shilpa Medicare Limited started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of API and Formulation globally in different regulated markets.
Read also: Shilpa Medicare gets USFDA approval for lung cancer injection Pemetrexed
Raichur Unit II is a 100% Export Oriented API Unit and spread over 22.4 acres (906304 sq.m) and is located just adjacent to Hyderabad- Raichur National Highway and around 166 kilometers from Hyderabad International Airport. This unit is certified by ISO 14001:2004 and approved by USFDA, WHO-GMP, EUGMP, TGA, PMDA, KFDA, TPD . Unit have state-of- Art ten manufacturing blocks (Oncology - 05 and Non-Oncology - 05). The total Non-Oncology products manufacturing reactor volume is 53000L and Oncology products manufacturing reactor volume is 122000L.
This unit has expertise in asymmetric synthesis, chiral technology, reduction reactions, customized synthesis/CRAMS activities.
