Senores Pharma arm facility gets 3 USFDA observations
Ahmedabad: Senores Pharmaceuticals Limited has announced that the United States Food & Drug Administration (USFDA) has issued three 483 observations for the manufacturing facility of Havix Group Inc. D/B/A Aavis Pharmaceuticals, a Material Subsidiary of the Company situated at 9488 Jackson Trail Road, Hoschton, Georgia 30548, USA.
The inspection was conducted from July 21, 2025 to July 25, 2025.
"We hereby inform that Havix Group Inc. D/B/A Aavis Pharmaceuticals, a Material Subsidiary of the Company situated at 9488 Jackson Trail Road, Hoschton, Georgia 30548, USA has completed the United States Food & Drug Administration (“USFDA”) inspection of its manufacturing facility from July 21, 2025 to July 25, 2025 with 3 (Three), 483 observations," Senores stated in a BSE filing.
Senores Pharmaceuticals Limited is a global, research-driven pharmaceutical company engaged in developing and manufacturing a wide range of pharmaceutical products predominantly for the US, Canada, and other regulated and emerging markets across various therapeutic areas and dosage forms. The companies’ current portfolio includes 61 ANDA and 22 CMO/CDMO commercial products that are permitted for distribution in the USA. Senores is also engaged in the development and manufacturing of complex generics certified by global food and drugs authorities and delivers generic drugs for emerging markets, catering to more than 40 countries. The company currently has approval from regulatory bodies of more than 10 countries for its manufacturing facility in Chhatral for emerging markets with over 280 product registrations and 630 product applications. Senores also manufactures critical care injectables and Active Pharmaceutical Ingredients (“API”). Senores has 2 manufacturing facilities for formulations – one in Atlanta, US which is USFDA approved and DEA, TAA & BAA compliant for controlled substances and government supplies & other is in Chhatral, Ahmedabad, India approved by WHO-GMP to cater to emerging markets. The company also has 2 manufacturing facilities for API in India, both located around Ahmedabad, with one in Chhatral and the other in Naroda.
