Drug Approval | November 02, 2024
USFDA inspection of Shilpa Medicare Unit VI at Bengaluru
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
The inspection concluded with the issuance of Form 483 with four observations which are procedural in nature
GBM affects nearly 13,000 patients annually in the US and approximately 300,000 globally
Bortezomib Injection is approved for subcutaneous or intravenous use. It is available as a single dose vial of 3.5 mg/1.4 mL (2.5 mg/mL)
Nor UDCA is likely to be a first-in-class treatment option for NAFLD in India
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
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