FDA Approves Generic Oseltamivir Phosphate Capsules
Taj Pharmaceuticals FDA Approvals of Oseltamivir Continues the Company’s Rise in the Generic Market. Taj Pharmaceuticals, the Mumbai based manufacturing & marketing affiliate of Taj Pharma Group, located in Mumbai, India, recently received FDA approval for their generic versions of Oseltamivir Phosphate Capsules.
The company was notified earlier this year, that Oseltamivir Phosphate 30mg, 40mg, and 75mg capsules, brand originator of drug rated to Roche’s brand Tamiflu©, received final approval from the Food and Drugs Administration. Oseltamivir is indicated in adults and children including full term neonates who present with symptoms typical of influenza, when influenza virus is circulating in the community. Efficacy has been demonstrated when treatment is initiated within two days of first onset of symptoms. Recent published data reports combined brand and generic sales for the product exceeded $188.4 MIL. The total unit sales have increased approximately 10% over the preceding 12 month period. The company anticipates shipping the product shortly.
Most recently, Taj Pharmaceuticals, received approval for Oseltamivir Phosphate 30mg, 45mg, and 75mg capsules. The product is used to treat symptoms caused by the flu virus (influenza) that include blocked nasal passages, fever/chills, aches, and fatigue. Combined 12 month sales data for brand and generics was over $188 MIL. As a seasonal therapy, sales for the product may fluctuate depending on the severity of the flu season. Due to a higher than average number of reported flu cases over the past 12 months, product sales increased 46% over the previously reported 12 month period.
Abhishek Kumar Singh, Taj Pharmaceuticals CEO Global Generics Operations, states, “Taj Pharma’s FDA approvals for generic Oseltamivir capsules continues to demonstrate the strength of the organization’s R&D capabilities. Being vertically integrated with API provides the scale and supply chain surety that customers seek when selecting a partner for a potentially high volume seasonal products including Oseltamivir. We look forward to gaining several more important FDA approvals over the next 12 months.”
Taj Pharmaceuticals is engaged in the development and manufacturing of API (active pharmaceutical ingredients), KSMs (key starting materials), and product intermediates. Taj Pharmaceuticals is the global leader in this generic pharmaceuticals drugs. Additionally, the company also manufactures finished dose oral solids, liquids, and specialty injectable products in 45 markets throughout the world, doing business in the India, Russia, MENA and Asian countries as as Taj Pharmaceuticals.
For more information, visit the company’s website www.tajpharma.com