Drug Approval | June 27, 2025
SMS Pharmaceuticals completes USFDA inspection at Central Laboratory Analytical Services
The inspection concluded with zero Form 483 observations
The inspection concluded with zero Form 483 observations
The company's decision to withdraw the MAA was due to the timing of the availability of Chemistry Manufacturing and Controls
Viatel bioresorbable polymers are increasingly used in dental and orthopedic implants
Changhua site meets international regulatory standards for global medical applications
Bonthapally facility is one of the world's largest single-site Paracetamol API manufacturing plants by volume
BASF strengthens its commitment to the biopharma and pharmaceutical ingredients industries through a new investment in North America
UFlex is the first and only Indian company to receive USFDA approval for its technology and capacity to recycle all three materials
Sun Pharma gets 8 observations from USFDA for Halol facility
SUP will obtain regulatory approvals for selling Tiotropium DPI in China
The use of Apisolex polymer excipient has been proven to increase the solubility of certain APIs by as much as 50,000-fold
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