Drug Approval | March 18, 2023
Briefs: Man Industries, Jeevan Scientific Technology, Unichem and Torrent Pharmaceuticals
Man Industries (India) Limited has received a new export order of approximately Rs. 1,300 crores.
Man Industries (India) Limited has received a new export order of approximately Rs. 1,300 crores.
Lupin Bioresearch Centre conducts BA/BE, PK/PD, In-vitro BE and biosimilar studies.
The company will be submitting the responses to US FDA observations within stipulated timeline
The business serves the healthcare and laboratory sectors on the west coast of the United States.
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
The audit was commenced for newly renovated manufacturing Block 1, Block 2, and Block 3
Alkem has submitted a detailed corrective and preventive action (CAPA) plan to the regulator within the stipulated timelines.
Cipla has received 8 inspectional observations in Form 483
The EIR was issued post the last inspection of the facility conducted from October 17, 2022 to October 29, 2022
USFDA has issued an Establishment Inspection Report (EIR) for Piramal Pharma Limited manufacturing facility located at Lexington (Kentucky, USA) and the inspection has now been successfully closed by the USFDA
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