Drug Approval | June 16, 2023
Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam
The company will submit its comprehensive response on these observations to the US FDA
The company will submit its comprehensive response on these observations to the US FDA
The company has now received the Establishment Inspection Report (EIR) indicating closure of the inspection
The new range of HDPE bottles is compliant with US FDA, EU regulations and Chinese DMF registration for use in dry pharmaceutical applications
Granules now has a total of 58 ANDA approvals from US FDA
Metoprolol Succinate ER Tablets are indicated for the treatment of hypertension in order to lower blood pressure.
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
Venlafaxine HCl extended-release capsules are indicated for the treatment of: Major Depressive Disorder
This latest audit re-emphasizes Hikal's commitment towards maintaining the best in class quality, compliance and regulatory standards across our manufacturing sites
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