Drug Approval | June 27, 2024
Shilpa Medicare Bio Analytical unit gets "No Action Indicated" classification from USFDA
This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies
This Unit of Shilpa Medicare is engaged in testing biological samples of clinical studies
Pemetrexed Injection is used as a drug, in the treatment of non-small cell lung cancer in combination with other chemotherapy agents
This newly set up Centre for bio-analytical testing has already received European Regulatory Authority clearance recently
Varenicline is indicated for smoking cessation in adults
The company intends to respond to the two minor observations within the stipulated time
The matter of Arbitration between Shilpa Medicare Limited and Celltrion towards supply and distribution agreement
This product has sales of about US$ 20 million in Europe
This inspection is the fourth major regulatory inspection (after Russia, Canada and Brazil), cleared by this site in the past two years
The composition of ORAAL is protected by a granted patent in India until November 2033
This approval has come from the company's finished dosage form manufacturing facility
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