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Zydus Lifesciences Expands US Market Presence with New Drug Approvals

16 July 20243 mins read by Angel One
Zydus Lifesciences received the US FDA approval to market Sacubitril/Valsartan tablets and tentative approval for Diroximel Fumarate capsules.
Zydus Lifesciences Expands US Market Presence with New Drug Approvals
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On July 10, 2024, Zydus Lifesciences Limited announced that the company received final approval from the United States Food and Drug Administration (USFDA) to market Sacubitril and Valsartan Tablets, available in dosages of 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg (branded as Entresto® tablets in the US).

This combination medication is prescribed for treating chronic heart failure in adults, aiming to reduce the risk of death and hospitalisation. The tablets will be produced at Zydus’s formulation manufacturing facility in Moraiya, Ahmedabad, India. Notably, Sacubitril and Valsartan tablets had impressive annual sales of USD 5,483 million in the United States as of May 2024, according to IQVIA.

Simultaneously, Zydus Lifesciences Limited received tentative approval from the USFDA to market Diroximel Fumarate Delayed-Release Capsules, 231 mg (known as Vumerity® Delayed-Release Capsules in the US).

This medication is intended to treat relapsing forms of multiple sclerosis (MS) in adults. These capsules will be manufactured at the group’s formulation facility in Ahmedabad SEZ, India. Diroximel Fumarate Delayed-Release Capsules had annual sales of USD 847.4 million in the United States, as reported by IQVIA in May 2024.

These approvals underscore Zydus Lifesciences’ robust capabilities in pharmaceutical manufacturing and regulatory compliance. As of March 31, 2024, the group had secured 399 approvals and filed over 460 Abbreviated New Drug Applications (ANDAs) since commencing the filing process in the fiscal year 2003-04.

The company’s consistent efforts in expanding its product portfolio and entering the US market highlight its commitment to providing accessible and high-quality medications globally. These approvals are expected to significantly bolster Zydus’s presence in the competitive US pharmaceutical market, contributing to its growth and enhancing its reputation as a reliable manufacturer of essential drugs.

About Zydus Lifesciences Limited

Zydus Lifesciences Limited, formerly known as Cadila Healthcare Limited, is a prominent Indian pharmaceutical company and a fully integrated global healthcare provider. With extensive expertise in healthcare, Zydus excels across the entire pharmaceutical value chain. The company is known for its capabilities in formulations, active pharmaceutical ingredients, animal healthcare products, and wellness products. Zydus has established a reputation among Indian pharmaceutical companies for delivering comprehensive and holistic healthcare solutions.

On July 11, 2024, the share price of Zydus Lifesciences Ltd opened at ₹1,203.00, touching the day’s high at ₹1,203.00, as of 9:39 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.

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