The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
Pharmaceutical sales was flat and stood at Rs. 309 crore as compared to Rs. 308 crore in Q4 FY22
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
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