News | December 06, 2025
Briefs: IOL Chemicals & Pharmaceuticals, Ipca Laboratories and Anuh Pharma
Ipca Laboratories receives three observations from USFDA for API facility at Tarapur
Ipca Laboratories receives three observations from USFDA for API facility at Tarapur
This inspection was conducted following the warning letter issued by the USFDA
The PCR-based test, delivered via Roche’s cobas liat system, allows results to be obtained during a patient consultation in GP practices and Emergency Rooms
The company is excluding data from the affected sites to maintain the study's integrity
FDA's withholding of the PRV was contrary to law because no drug product containing phenobarbital sodium was 'previously approved'
LYMPHIR addresses a clear clinical need in a disease with limited treatment options
The company also revealed that MK-2214 has received Fast Track Designation from the U.S. Food and Drug Administration
Patients can now get the starting 2.5 mg dose for $299 per month
This relates to the manufacture and supply of Human Recombinant Insulin (rh- Insulin) and Biosimilar Pegfilgrastim Drug Substance to the United States
The fresh capital will propel Cordance into its first-in-human clinical trial
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