Briefs: Shivalik Rasayan and Dr. Reddy's Laboratories
Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial
Shivalik Rasayan Limited has issued LOA to Medicamen Biotech to use its DMF grade Bortezomib API for formulation of Bortezomib injection 3.5mg/ vial
USFDA concludes inspection at Zydus' formulation manufacturing facility at SEZ 2, Ahmedabad
The zero-observation outcome reflects the company's robust quality management systems and commitment to excellence in its operations.
The inspection closed with zero observations
The company will submit its comprehensive response on these observations to the US FDA
Diclofenac Sodium and Misoprostol Delayed Release Tablets USP, 50mg/200 mcg and 75mg/200 mcg had annual sales of USD 13 mn in the United States
The company has extended its full co-operation and support to the officials of the Income Tax Department
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
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