Unichem receives Form 483 from USFDA with 3 observations for Roha API facility
The company will provide the necessary response to USFDA within stipulated 15 days
The company will provide the necessary response to USFDA within stipulated 15 days
BASF strengthens its commitment to the biopharma and pharmaceutical ingredients industries through a new investment in North America
Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume
The transaction is expected to close in Q2 FY 2026
The company received seven observations in the Form-483
The GMP-compliant facility with automated environmental monitoring accommodates both white room and class 7 and 8 cleanroom space
The company received one observation in the Form-483
The inspection concluded successfully, with the facility found to be in compliance with the required regulations
The decision to advance subcutaneous and oral amycretin into phase 3 is based on feedback received from regulatory authorities
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