Alkem Laboratories receives 7 observations following US FDA inspection at Daman facility
The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026
The US regulator conducted an inspection at the Amaliya manufacturing plant between April 20 and May 1, 2026
The Puducherry facility, dedicated to Ibuprofen and its derivatives, is equipped with advanced infrastructure to serve both domestic and international markets
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
This GMP and Pre-Approval Inspection is part of the routine business operations and the company shall submit to US FDA within the stipulated timeline
18-year veteran Saharsh will position the CDMO as a premier global API process development and commercial manufacturing specialist
The EIR was issued with an inspection classification of Voluntary Action Indicated (VAI) post the inspection conducted in June 2025
Sun Pharma's Halol plant gets OAI classification from US FDA inspection
Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume
The company received seven observations in the Form-483
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