USFDA Approval for Gland Pharma BP Injection in Septic Shock

Hyderabad-based Gland Pharma, a luminary in the biopharmaceutical industry since its inception in 1978, has made significant strides towards solidifying its position as an international powerhouse in the sector of injectable pharmaceuticals. With a robust business-to-business model, the company’s operations extend to more than 60 countries, including key global markets such as the US, Europe, and India. Specializing in sterile injectables, Gland Pharma’s product portfolio consists of an array of formulations including vials, ampoules, pre-filled syringes, and oncology solutions. These products cater to a wide spectrum of medical needs, underscoring the company’s commitment to healthcare innovation.

Gland Pharma recently acquired approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Angiotensin II Acetate Injection 2.5 mg/mL. This approval marks a significant milestone for the company, as it provides a crucial treatment option for adults grappling with septic shock—a medical condition with high unmet needs.

The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), GIAPREZA, developed by La Jolla Pharma LLC. The injection is indicated for increasing blood pressure in adults diagnosed with septic or other distributive shocks. As the exclusive First-to-File, Gland Pharma is eligible for 180 days of generic drug exclusivity.

This validation from the USFDA not only bolsters Gland Pharma’s commitment to delivering quality healthcare solutions but also paves the way for new opportunities for growth and expansion. The endorsement from the USFDA underscores the safety and efficacy of the BP injection, potentially fostering investor confidence, and amplifying the company’s market share. The product holds immense promise for patients diagnosed with septic shock, offering them access to a well-established and proven treatment option.

In addition to the BP injection, Gland Pharma also received approval from the USFDA in April for its ANDA for Latanoprostene Bunod Ophthalmic Solution,0.024%. This product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), VYZULTA Ophthalmic solution, 0.024%, produced by Bausch and Lomb, Inc.

In an industry that is perpetually evolving, Gland Pharma’s innovative approach and global presence position them well for further advancements in the arena of injectable medications. This is particularly true in critical care scenarios like septic shock, where the company’s products could make a substantial difference. With US sales of approximately USD 58 million for the twelve months ending March 2025, the company’s advancements point towards a promising future in the global pharmaceutical landscape.