Drug Approval | July 17, 2025
Shilpa Medicare receives EIR from USFDA for Unit VI, Bengaluru
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
This facility is capable of manufacturing, packaging, testing, storage and distribution of two types of complex dosage forms
The receipt of EIR reaffirms the company's commitment to maintaining global quality standards
Capricor’s BLA for Deramiocel received Priority Review in March 2025
Emcure Pharmaceuticals successfully completes USFDA PAI of Oncology facility
This was a full GMP inspection of the entire facility with specific focus on Ondansetron Oral Film drug product
The audit has been concluded with no major observations
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 will provide the necessary response to USFDA within stipulated 15 days
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