USFDA approves Gland Pharma Plerixafor Injection

Written by Ruchika Sharma Published On 2024-05-07T13:30:01+05:30 | Updated On 7 May 2024 1:01 PM IST

USFDA approves Gland Pharma Plerixafor Injection

Hyderabad: Generic injectable-focused pharmaceutical company, Gland Pharma Limited, has received approval from the United States Food and Drug Administration (USFDA) for Plerixafor Injection, 24 mg/1.2 mL (20 mg/mL), Single-Dose Vial (Product).

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), MOZOBIL (plerixafor) injection of Genzyme Corporation, a Sanofi Company.

The Product is a hematopoietic stem cell mobilizer indicated in combination with filgrastim to mobilize hematopoietic stem cells (HSCs) to the peripheral blood for collection and subsequent autologous transplantation in patients with non-Hodgkin's lymphoma or multiple myeloma.

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

According to IQVIA, the product had US sales of approximately USD 152 million for the twelve months ending January 2024.

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 bags USFDA nod for Cetrorelix Acetate for Injection

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751