Gland Pharma bags USFDA nod for amyotrophic lateral sclerosis injection Edaravone

Hyderabad: Gland Pharma Limited, a generic injectable-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for Edaravone Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL), Single-Dose Bags.

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Radicava Injection, 30 mg/100 mL (0.3 mg/mL) and 60 mg/100 mL (0.6 mg/mL) of Mitsubishi Tanabe Pharma Corporation.

The Product is used to treat amyotrophic lateral sclerosis (ALS), a condition in which the nerves that control muscle movement slowly die, causing the muscles to shrink and weaken.

The Company expects to launch this Product through its marketing partner within FY25.

According to IQVIA, the product had US sales of approximately USD 19 million for the twelve months ending January 2024.

Gland Pharma has also announced the receipt of approval from the USFDA for Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial (Product).

Read also: USFDA approves Gland Pharma Plerixafor Injection

Gland Pharma was established in 1978 in Hyderabad. The Company has grown over the years from a contract manufacturer of small-volume liquid parenteral products to a injectable-focused companies. Its global footprint is spread across 60 countries, including the United States, Europe, Canada, Australia, India, and other markets. It operates primarily under a business-to-business (B2B) model and has an excellent track record in developing, manufacturing, and marketing sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.

Read also: Gland Pharma appoints Satnam Singh Loomba as COO, Senior Management Personnel