News | August 28, 2023
Gland Pharma receives 2 observations under 483 for Pashamylaram facility
The company is committed to address the observations and will submit its response to US FDA within the stipulated time
The company is committed to address the observations and will submit its response to US FDA within the stipulated time
Construction will begin this year with the new capacity anticipated by 2025
Cooperative agreement with U.S. Government to advance U.S. biopharma industry and ensure pandemic preparedness
Supriya Lifescience Limited has informed that the European Directorate for the Quality of Medicines (EDQM) has granted Attestation of Inspection (EU-GMP) for Lote API Facility, Ratnagiri, Maharashtra.
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This clinical study will inform operational logistics and use of AV7909 should an anthrax emergency occur.
The company has received 1 (ONE) observation on Form 483 with respect to ANDA filed for the product to be manufactured at the said Facility.
Novavax' vaccine is the first protein-based COVID-19 vaccine authorized in the U.S.
Construction will begin in early 2023, and the plant is scheduled to go onstream in 2025
This agreement is in addition to the $92 million filling line expansion announced in November 2021
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