Drug Approval | July 24, 2023
Aurobindo Pharma gets 3 observations from USFDA for Unit 3 at Bachupally Village
Aurobindo will respond to the US FDA within the stipulated timelines
Aurobindo will respond to the US FDA within the stipulated timelines
The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
The company will submit its comprehensive response on these observations to the USFDA
In Phase 3 CCTG IND.227/KEYNOTE-483 trial, KEYTRUDA plus chemotherapy also demonstrated statistically significant improvements in PFS and ORR compared to chemotherapy alone
Pharmaceutical sales was flat and stood at Rs. 309 crore as compared to Rs. 308 crore in Q4 FY22
This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites
Dr. Reddy's Laboratories has been issued a Form 483 with four observations
The company will submit its comprehensive response on these observations to the US FDA within the stipulated time
The facility is over 79,000 square feet and is equipped with packaging lines
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