Zydus Gains USFDA Nod for Parkinson’s Drug

On August 27, 2024, Zydus Lifesciences Limited and its subsidiaries received final approval from the US Food and Drug Administration (USFDA) to market Amantadine extended-release capsules in 68.5 mg strength, along with a tentative approval for the 137 mg strength.

These capsules, equivalent to Gocovri®, are used to treat dyskinesia in Parkinson’s disease patients who are on levodopa therapy, either alone or with other dopaminergic medications. The drug will be produced at Zydus’s formulation manufacturing facility located in Ahmedabad SEZ – II, India. This approval grants Zydus 180 days of exclusivity for the 68.5 mg capsules.

Zydus now has a total of 400 approvals and has filed over 465 Abbreviated New Drug Applications (ANDAs) since it began the filing process in the 2003-04 financial year.

In their recent press release on August 23, 2024, Zydus Lifesciences Limited, through its wholly-owned subsidiary, entered into an agreement with Perfect Day Inc. to acquire Perfect Day’s approximately 50% stake in Sterling Biotech Limited (SBL). This transaction will result in SBL becoming a 50:50 joint venture with equal board representation.

The JV aims to establish a state-of-the-art facility to produce animal-free fermented protein for global markets, addressing the growing demand for ethical, sustainable nutrition. This move marks Zydus’s entry into biotech products targeting health and nutrition, especially for consumers seeking animal-free protein. The partnership will leverage Perfect Day’s technological expertise and Zydus’s manufacturing capabilities, boosting India’s role in the global supply chain.

About Zydus Lifesciences Limited

Zydus Lifesciences is a leading pharmaceutical company in India, focused on developing and selling a wide range of pharmaceutical products. The company holds a strong market position in several categories, with many of its brands being leaders in their respective segments. Zydus is significant in various therapeutic areas, including pain management, cardiovascular diseases, urology, and anti-infectives. Additionally, it offers a variety of over-the-counter healthcare products. Zydus distributes its medicines through retail pharmacies, hospitals, and clinics across India and also exports to multiple countries worldwide.

On August 28, 2024, Zydus Lifesciences Ltd’s share price opened at ₹1,152.00, touching the day’s high of ₹1,156.00 as of 10:25 AM on the NSE.

Disclaimer: This blog has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.