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Drug Approval | April 07, 2024
Cipla Patalganga facility gets 6 USFDA observations
The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
The regulator carried out a routine current Good Manufacturing Practices (cGMP) inspection from March 28 to April 4.
USFDA inspects Zydus Lifesciences’ Ahmedabad SEZ Onco manufacturing plant
The inspection at Unit 1 by the USFDA has been successfully completed, with no observations under Form 483
New facility includes 20KL of single use drug substance capacity coupled with drug product filling capacity of up to one million vials per day
The company will provide comprehensive response to USFDA for the observations
This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently
Cipla completes transfer of Generics Business Undertaking
Suven Pharmaceuticals’ API and forumulations facilities complete USFDA inspection successfully
Laurus Synthesis receives Form 483 with 5 observations from USFDA
Dr. Reddy's Laboratories has been issued a Form 483 with three observations
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