Gland Pharma bags USFDA nod for Cetrorelix Acetate for Injection

Written By : Ruchika Sharma |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-04-29T15:06:06+05:30 | Updated On 29 April 2024 3:06 PM IST

Cetrorelix Acetate for Injection is used to prevent premature LH surges in women undergoing controlled ovarian stimulation.

Hyderabad: Gland Pharma Limited, a generic injectable-focused pharmaceutical company, has received approval from the United States Food and Drug Administration (USFDA) for Cetrorelix Acetate for Injection, 0.25 mg/vial, Single-Dose Vial (Product).

The Product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Cetrotide for Injection, 0.25 mg/vial, of EMD Serono, Inc.

The Company expects to launch this Product in the near-term through its marketing partner. According to IQVIA, the product had US sales of approximately USD 129 million for the twelve months ending February 2024.

Cetrorelix Acetate for Injection is used to prevent premature LH surges in women undergoing controlled ovarian stimulation. It blocks the effects of a natural hormone called gonadotropin-releasing hormone (GnRH), which controls the secretion of another hormone called luteinizing hormone (LH), which induces ovulation during the menstrual cycle.

"Cetrorelix further expands the company's fertility product line, underscoring its commitment to developing and manufacturing complex injectables to meet patients' unmet needs," Gland stated in a BSE filing.

Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become one of the largest injectable-focused companies, with a global footprint 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 tentative USFDA nod for Angiotensin II Injection for low BP treatment

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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

Dr. Kamal Kant Kohli

Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751