Regulatory Approval Details
Gland Pharma Limited has received approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Methylprednisolone Acetate Injectable Suspension USP. The approval covers multiple dosage forms and strengths:
- 40 mg/mL Single-Dose Vials
- 80 mg/mL Single-Dose Vials
- 200 mg/5 mL (40 mg/mL) Multiple-Dose Vials
- 400 mg/10 mL (40 mg/mL) Multiple-Dose Vials
- 400 mg/5 mL (80 mg/mL) Multiple-Dose Vials
Therapeutic Equivalence and Reference Product
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Depo-Medrol Injectable Suspension, 40 mg/mL and 80 mg/mL, manufactured by Pfizer Inc.
Medical Indications
The product is indicated for the treatment of multiple medical conditions across various therapeutic areas:
- Allergic States
- Dermatologic Diseases
- Endocrine Disorders
- Gastrointestinal Diseases
- Hematologic Disorders
- Neoplastic Diseases
- Nervous System conditions
- Ophthalmic Diseases
- Renal Diseases
- Respiratory Diseases
- Rheumatic Disorders
- Miscellaneous indications
Market Size and Commercial Opportunity
According to IQVIA data, the Methylprednisolone injection market in the United States had sales of approximately USD 214 million for the twelve months ending August 2026.
Company Background Context
Gland Pharma is described as a generic injectable and ophthalmic-focused pharmaceutical company established in 1978 in Hyderabad. The company has grown 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, and India.
The company operates primarily under a business-to-business (B2B) model and has expertise in developing, manufacturing, and marketing sterile injectables. Their product range includes vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology products, and ophthalmic solutions. Gland Pharma is noted for having pioneered Heparin technology in India.
Regulatory Framework Disclosure
The announcement was made pursuant to Regulation 30 read with Part A of Schedule III of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015.
Corporate Contact Information
The press release was signed by Pallerlamudi Sampath Kumar, Company Secretary & Compliance Officer of Gland Pharma Limited. The company's registered office is located at Survey No. 143-148, 150 & 151, Near Gandimaisamma 'X' Roads D.P. Pally, Dundigal, Dundigal-Gandimaisamma Mandal, Medchal-Malkajgiri District, Hyderabad 500043, Telangana, India.