Zydus Life Science , a prominent player in the pharmaceutical industry, has achieved a significant milestone in its U.S. market expansion strategy. The company has successfully obtained final approval from the U.S. Food and Drug Administration (USFDA) for its Diltiazem Hydrochloride Tablets, paving the way for the medication's marketing and distribution in the United States.

Regulatory Breakthrough

The USFDA's final approval marks a crucial step for Zydus Lifesciences, allowing the company to introduce its Diltiazem Hydrochloride Tablets to the American market. This regulatory green light is expected to strengthen the company's position in the highly competitive U.S. pharmaceutical landscape.

About Diltiazem Hydrochloride

Diltiazem Hydrochloride is a widely recognized calcium channel blocker, primarily used in the treatment of:

• Hypertension (high blood pressure)
• Angina (chest pain)
• Certain types of arrhythmias

The medication works by relaxing blood vessels and improving blood flow, making it easier for the heart to pump blood.

Market Implications

This approval could potentially open up new revenue streams for Zydus Lifesciences in the U.S. market. The introduction of Diltiazem Hydrochloride Tablets adds to the company's growing portfolio of FDA-approved medications, potentially enhancing its competitive edge in the global pharmaceutical industry.

Looking Ahead

As Zydus Lifesciences prepares to launch Diltiazem Hydrochloride Tablets in the United States, industry observers will be keen to see how this development impacts the company's market share and financial performance. The successful commercialization of this product could play a significant role in the company's growth strategy in the U.S. pharmaceutical market.

This latest USFDA approval underscores Zydus Lifesciences' commitment to expanding its presence in key global markets and its focus on delivering high-quality pharmaceutical products to patients worldwide.

Zydus Life Science , a leading Indian pharmaceutical company, has successfully completed the acquisition of a controlling stake in Amplitude Surgical SA, a French orthopedic surgical technology firm. The deal, which was first announced on March 11, 2025, marks a significant expansion for Zydus into the global orthopedic market.

Key Highlights of the Acquisition

• Zydus acquired an 85.6% stake in Amplitude Surgical for €256.8 million (approximately ₹2,310.00 crore).
• The acquisition was completed on July 29, 2025, through Zydus MedTech (France) SAS, a wholly-owned subsidiary of Zydus MedTech Private Limited.
• The purchase price was set at €6.25 per share.

Upcoming Mandatory Tender Offer

Following the completion of the block acquisition, Zydus is set to initiate further steps to consolidate its ownership:

• A simplified mandatory tender offer will be filed on July 30, 2025, for the remaining outstanding shares at the same price of €6.25 per share.
• Seven shareholders, representing 4.7% of Amplitude Surgical's share capital, have already committed to participate in the tender offer.
• Upon completion of the offer, Zydus is expected to hold more than 90% of Amplitude Surgical's capital and voting rights.
• Zydus intends to implement a squeeze-out of remaining minority shareholders after the tender offer.

Timeline and Regulatory Approval

• The tender offer is anticipated to open in September 2025, subject to clearance from the French Financial Market Authority (Autorité des marchés financiers, AMF).
• No additional regulatory approvals are required for the tender offer.

Management and Board Developments

• Olivier Jallabert will continue in his role as CEO of Amplitude Surgical.
• Amplitude Surgical's Board of Directors unanimously welcomed the offer on July 28, 2025.
• An independent expert, Finexsi, provided a fairness opinion on the offer.

About Amplitude Surgical

Amplitude Surgical, founded in 1997 in Valence, France, is a prominent player in the surgical technologies market for lower limb orthopedics. The company:

• Develops and markets high-end orthopedic surgery products, focusing on hip and knee pathologies.
• Collaborates closely with surgeons to create innovative solutions.
• Has an international presence through subsidiaries and a network of agents and distributors in over 30 countries.
• Employed 429 people and generated revenue of nearly €111.00 million as of June 30, 2025.

Strategic Implications for Zydus Lifesciences

This acquisition aligns with Zydus Lifesciences' mission to empower people with healthier and more fulfilled lives. By integrating Amplitude Surgical's expertise in orthopedic surgical technologies, Zydus is poised to:

• Expand its global footprint in the healthcare sector.
• Enhance its portfolio in the high-value orthopedic market.
• Leverage synergies between its existing pharmaceutical business and Amplitude's medical device capabilities.

The successful completion of this acquisition marks a significant milestone for Zydus Lifesciences, positioning the company for growth in the global orthopedic surgical market and reinforcing its commitment to innovative healthcare solutions.