Drug Approval | May 07, 2024
Alembic Pharmaceuticals receives EIR from USFDA for oncology formulation facility
With this, for all our USFDA facilities, EIRs are in place
With this, for all our USFDA facilities, EIRs are in place
Eugia Pharma Specialities receives 7 observations from USFDA for Unit II
Colchicine Capsules are indicated for prophylaxis of gout flares in adult
US FDA and EMA accepted filings based on the data from OCARINA II, with EU approval anticipated mid-2024 and U.S. approval anticipated September 2024
Sun Pharma's Dadra facility receives OAI status from US FDA
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This facility manufactures APIs & formulations of oncology and non-oncology products.
These observations are procedural in nature and will be responded within the stipulated time
The observations are procedural in nature and will be responded to within the stipulated time
For the treatment of stenotic lesions of arteriovenous fistula in the haemodialysis management of chronic renal failure
The facility will manufacture tablets, capsules, and injections for the oncology segment
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