Shilpa Pharma Lifesciences’ Unit 2 Raichur has cleared the ANVISA-Brazil GMP inspection
The Unit has been issued GMP Certification from ANVISA-Brazil
The Unit has been issued GMP Certification from ANVISA-Brazil
The inspection has concluded successfully on 1st September 2023 without any critical/major observation
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Shilpa’s product has been approved as a generic version to the innovator - Chantix Tablets, 0.5 mg and 1 mg, of PF Prism C.V. (PF Prism)
Raichur site is the group’s largest API facility and part of a wider network of seven sites
Pemetrexed Injection is used as a drug, in the treatment of non-small cell lung cancer in combination with other chemotherapy agents
Varenicline is indicated for smoking cessation in adults
This approval has come from the company's finished dosage form manufacturing facility
Shilpa Medicare Limited is the first company to receive approval for Manufacturing & Market of Pemetrexed Injection 10 ml, 50 ml, 85 ml, and 100 ml in India
The company is already marketing the 4 mg and 10 mg strengths
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