Granules India receives Form 483 with 1 observation from USFDA for Bonthapally API unit 1
Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume
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
The collaboration furthers AstraZeneca’s presence in China following the $2.5bn investment in Beijing
The project will be instrumental in enhancing the company's API manufacturing capacity and global reach
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