Drug Approval | January 20, 2024
Shilpa Medicare receives Europe approval for Amifampridine Tablets, 10 mg
This product has sales of about US$ 20 million in Europe
This product has sales of about US$ 20 million in Europe
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
The inspection has concluded successfully on 1st September 2023 without any critical/major observation
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
This is the second US FDA GMP inspection of this facility within one year
The company will be submitting the responses to US FDA observations within stipulated timeline
This registration enables companies to register the products (Orodispersible films and Transdermal systems) in UAE for commercialization
The facility is identified as a testing laboratory in numerous ANDAs filed by Shilpa Medicare Limited and its agreed parties
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