Drug Approval | March 22, 2025
SMS Pharmaceuticals completes USFDA inspection at Hyderabad facility
The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483
The inspection, conducted from March 17 to March 21, 2025, concluded with one observation in Form 483
Through strong industry cooperation, significant investment, and smart policy backing, API manufacturing may become self-reliant
Havix was incorporated under the laws of the State of Delaware on February 17, 2015
USFDA inspection at Alembic Pharma's Bioequivalence facility
This achievement underscores the company’s steadfast commitment to sustainability, corporate responsibility, and ESG excellence
Carson brings with him over two decades of experience in Communications, Public Affairs, and Sustainability
The basket acquired, comprises of 13 ANDAs, which are approved by the USFDA and 1 ANDA, which is pending approval from the USFDA
Glenmark acquired the ANDA for Acetylcysteine Injection, 6 gm/30 mL (200 mg/mL) Single-Dose Vials from Aspen Pharma USA
This is Senores' second API manufacturing facility adding significantly to the existing API manufacturing capabilities.
This launch of Epinephrine Injection multiple-dose Vial is eligible for 180 days of CGT exclusivity under section 505(j)(5)(B)(v) of the FD&C Act.
Subscribe To Our Newsletter & Stay Updated
