Drug Approval | May 23, 2023
Shilpa Medicare Analytical Services Division gets VAI status from USFDA after GMP inspection
This is the second US FDA GMP inspection of this facility within one year
This is the second US FDA GMP inspection of this facility within one year
Dr. Reddy's Laboratories has been issued a Form 483 with four observations
The facility is over 79,000 square feet and is equipped with packaging lines
The company is addressing these observations
The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide
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 inspection concluded with no observations
Cipla has received 8 inspectional observations in Form 483
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