Drug Approval | June 29, 2025
Briefs: Neuland Laboratories and Granules India
Granules India receives 1 observation from USFDA for Chantilly facility
Granules India receives 1 observation from USFDA for Chantilly facility
J B Chemicals and Pharmaceuticals receives ANDA approval for Amitriptyline Hydrochloride Tablets from USFDA
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
Sun Pharma gets 8 observations from USFDA for Halol facility
The company received one observation in the Form-483
Zydus receives EIR for the API manufacturing facility at Ankleshwar
The company reported sustained increase in formulations' share despite slowdown in productivity of Gagillapur facility
Adjusted Profit After Tax (PAT) for the year ended March 31, 2025 was at Rs. 1,389.4 crore
The EIR was issued following an inspection of the facility conducted from June 10 to June 13, 2024
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