MSN Labs Obtains FDA Approval for Generic Abiraterone

MSN Labs Obtains FDA Approval for Generic Abiraterone

By Pharma Tech Outlook | Friday, August 09, 2019

Generic Abiraterone FDA approval marks the use of drugs in patients for the treatment of prostate cancer when used with steroid medication.

FREMONT, CA: MSN Labs, which is involved in the development and manufacturing of active pharmaceutical ingredients (APIs), key starting materials (KSMs), and product intermediates has received FDA approval to market Abiraterone Acetate 250 mg tablets, a generic version of the Zytiga product from Janssen Pharmaceuticals.

This FDA validation marks the ninth approval since March 2018 when Novadoz Pharmaceuticals, a subsidiary of MSN, started business activities for their finished dosage forms as the U.S. sales and marketing. Over the next 12 months, the organization expects new product launches to continue the meteoric entry of the organization and rise in the U.S. market.

For oncology drugs, MSN's approval for Abiraterone Acetate 250mg tablets indicates the treatment of prostate cancer when used with steroid medication. This is Novadoz's second oncology product, the first 150 mg & 500 mg Capecitabine tablets, the generic Xeloda version of Novartis, indicated the treatment of breast cancer.

Generic Abiraterone approval is essential to the organization as it continues to fill the portfolio with necessary products, particularly those used in the oncology class. These products offer great value to patients and customers and continue to build on the successful U.Ss market entry of Novadoz. The organization continues to concentrate on plans for the next 12 to 18 months to launch 10 to 12 additional products.

Since MSN has experienced early success in delivering generics to its customers on a reliable and consistent basis, it relies on the efforts to achieve further success with Abiraterone 250 mg tablets. Together with a robust generic pipeline, MSN's vertical integration with API and backward integration with primary starting materials and intermediates, plays a dominant factor in the ongoing achievement of the company.

MSN is a pioneer in the growth and manufacturing of APIs globally. The organization is one of the principal owners of active Drug Master Files (DMFs) and provides APIs to most generic pharmaceutical businesses based in the U.S. The firm also produces completely oral solids, liquids, and injectable goods in 65 markets worldwide. 

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