Drug Approval | June 19, 2023
Lupin receives EIR from FDA for its API manufacturing facility in Vizag
The inspection closed with the facility receiving an inspection classification of NAI
The inspection closed with the facility receiving an inspection classification of NAI
Panacea Biotec has announced the launch of its new range of high-quality pediatric food & nutritional products
The company will submit its comprehensive response on these observations to the US FDA
The EU certification will support supplies of drug products registered in Europe, from this manufacturing site
The company expects this approval in Baddi to pave the way for GMP certifications from European Medicines Agency and other PIC/S member nations
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.
The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.
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
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