BE’s Enoxaparin Sodium Injection Receives USFDA Approval

Hyderabad, June 7, 2023: Biological E. Limited (BE) is pleased to announce that it received final approval for an Abbreviated New Drug Application (ANDA) for the complex product Enoxaparin Sodium Injection USP, Pre-filled Syringes, from the U.S. Food and Drug Administration (USFDA) on June 06, 2023. Enoxaparin Sodium Injection was filed with the USFDA on March 23, 2020. BE has received 10 ANDA approvals from the USFDA so far. The USFDA approved BE’s Enoxaparin Sodium Injection USP, (30 mg/0.3 mL, 40 mg/0.4 mL, 60 mg/0.6 mL, 80 mg/0.8 mL, 100 mg/1 mL, 120 mg/0.8 mL, and 150 mg/1 mL) Single-Dose, Pre-filled Syringes. Enoxaparin Sodium is a is a low molecular weight heparin (LMWH) indicated for Prophylaxis of Deep Vein Thrombosis (DVT) in surgery (abdominal, hip replacement, knee replacement), treatment of acute DVT with or without pulmonary embolism and Prophylaxis of ischemic complications of unstable angina and myocardial infarction (MI), treatment of Acute ST-segment elevation myocardial infarction (STEMI). About Biological E. Limited Biological E. Limited (BE), a Hyderabad-based Pharmaceuticals & Biologics Company founded in 1953, is the first private sector biological products company in India and the first pharmaceutical company in Southern India. BE develops, manufactures and supplies vaccines and therapeutics. BE supplies its vaccines to more than 130 countries and its therapeutic products are sold in India and the USA, Europe. BE currently has 8 WHO-prequalified vaccines and 10 USFDA approved Generic Injectables in its portfolio. In recent years, BE has embarked on new initiatives for organisational expansion such as developing specialty injectable products for global markets as a means to manufacture APIs sustainably and developing novel vaccines for the global market. Please follow us on Facebook , LinkedIn and Twitter

The release as fetched from its publisher. biologicale.com ↗