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
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
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
Apremilast Tablets, 10 mg, 20 mg, and 30 mg is a generic equivalent of reference listed drug (RLD) OTEZLA of Celgene.
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
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