Zydus partners with CHEMI of Italy to launch Enoxaparin Sodium Injection in the United States

Zydus Pharmaceuticals Inc, USA (a 100% subsidiary of Cadila Healthcare Limited (Zydus Cadila), a leading innovation-driven, global healthcare provider, has signed a license and supply agreement with CHEMI SpA (“CHEMI”) of Italy, a subsidiary of Italfarmaco Group, to launch the generic equivalent of Sanofi Aventis’s branded product Lovenox® (Enoxaparin Sodium Injection) in seven dosage
strengths in the United States (US).

Under the agreement, CHEMI will manufacture and supply the Enoxaparin Sodium Injection which Zydus will commercialize in the US. CHEMI owns proprietary rights on a pharmaceutical product composed of Enoxaparin Sodium (Preservative Free) single-use pre-filled syringes, which is an AP-rated generic version of the branded product Lovenox®. CHEMI, utilizing their proprietary technology, will produce the Enoxaparin Sodium injection within proprietary manufacturing facilities located in Italy. CHEMI within ITF group is also vertically integrated on the Enoxaparin Sodium API manufacturing which ensures quality and an uninterrupted supply of the critical care product.

Speaking on the development, Managing Director of Cadila Healthcare Limited, Dr. Sharvil Patel said, “This partnership between Zydus and CHEMI is another step in our unwavering commitment to improving the supply of critical care drugs, which are vital in delivering quality patient care. In addition, this collaboration will bolster the Zydus injectable portfolio and demonstrates Zydus’ long-term
commitment to drive growth through investment in complex generic products. We’re proud to be the first Indian company to launch a generic version of Enoxaparin in the United States and are excited about this opportunity.”

Enoxaparin Sodium Injection, USP is used for prophylaxis of Deep Vein Thrombosis (DVT) in patients undergoing abdominal, hip or knee replacement surgery, and also for the treatment of acute DVT. Enoxaparin acts as blood thinner by producing an antithrombotic effect. Enoxaparin Injection had annual sales of approximately $513 million in the United States, according to IQVIA data as of June
2021.

About Zydus Cadila

Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures, and markets a broad range of healthcare therapies including small molecule drugs, biologic therapeutics and vaccines. The group employs 25,000 people worldwide and is dedicated to creating healthier communities globally.

About CHEMI SpA

CHEMI SpA is Milan, Italy based a leading company in the chemical-pharmaceutical area belonging to Italfarmaco Group. CHEMI specialized in the development, production and sales of high-quality generic Active Pharmaceutical Ingredient (APIs), complex to make generics, and peptides, with full manufacturing capabilities from API Synthesis to finished dosage formulation of injectable drugs. CHEMI has prominent experience in the development of Low-Molecular-Weight Heparin (LMWHs) and polysaccharide derivatives, peptides, oncological products.

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