The companies admitted taking part in the cartel in exchange for reduced fines but Alchem did not settle
Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume
The company will provide the necessary response to USFDA within stipulated 15 days
The company received one observation in the Form-483
The project will be instrumental in enhancing the company's API manufacturing capacity and global reach
The company received 1 (One) observation in the Form-483
Zydus receives EIR for the API manufacturing facility at Ankleshwar
The use of Apisolex polymer excipient has been proven to increase the solubility of certain APIs by as much as 50,000-fold
These observations are procedural in nature and none of them are related to data integrity
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