News ArticleGland Pharma Obtains USFDA Approval for Methylprednisolone Acetate Injectable Suspension in Varied Dosages
Approved product bioequivalent to Pfizer's Depo-Medrol with US sales around USD 214 million in 12 months ending August 2026
Gland Pharma Limited announced USFDA approval for its Methylprednisolone Acetate Injectable Suspension in single-dose and multiple-dose vials, matching Pfizer's Depo-Medrol reference drug. The product serves multiple therapeutic areas with US sales of $214 million for the past year.
Gland Pharma Limited
General / Other
Gland Pharma Limited has received approval from the US Food and Drug Administration (USFDA) for its Methylprednisolone Acetate Injectable Suspension USP across several single-dose and multiple-dose vial formulations.
The approved injectable suspension comes in 40 mg/mL and 80 mg/mL single-dose vials, as well as multiple-dose vials of 200 mg/5 mL (40 mg/mL), 400 mg/10 mL (40 mg/mL), and 400 mg/5 mL (80 mg/mL).
This product is bioequivalent and therapeutically equivalent to Pfizer Inc.'s reference listed drug, Depo-Medrol Injectable Suspension, available in similar dosage strengths.
Methylprednisolone Acetate Injectable Suspension is indicated for treating various conditions across different therapeutic areas, including allergic states, dermatologic diseases, endocrine disorders, gastrointestinal diseases, hematologic and neoplastic disorders, nervous system and ophthalmic diseases, renal and respiratory diseases, and rheumatic disorders.
According to IQVIA data, the relevant Methylprednisolone injection market had US sales amounting to approximately USD 214 million for the twelve months ending August 2026.
Highlights
- USFDA approval secured for Methylprednisolone Acetate Injectable Suspension USP in multiple vial dosages.
- Product matches Pfizer’s Depo-Medrol reference drug in bioequivalence and therapeutic use.
- Indicated for a wide range of medical conditions including allergic, dermatologic, endocrine, gastrointestinal, hematologic, neoplastic, nervous system, ophthalmic, renal, respiratory, and rheumatic diseases.
- US market sales for this injectable stood at about USD 214 million for the year ending August 2026.
Key Data Snapshot
What happened
- Gland Pharma received USFDA approval for Methylprednisolone Acetate Injectable Suspension in specific single-dose and multiple-dose vial formulations.
- The approval is for formulations with concentrations 40 mg/mL and 80 mg/mL in single-dose vials and multiple-dose vials of varying volumes and doses.
Key details
- The approved product is bioequivalent and therapeutically equivalent to Pfizer’s Depo-Medrol, the reference listed drug.
- Methylprednisolone Acetate Injectable Suspension is indicated for a broad array of therapeutic areas including allergic, dermatologic, endocrine, gastrointestinal, hematologic, neoplastic, nervous system, ophthalmic, renal, respiratory, and rheumatic disorders.
- IQVIA reports that US sales of the corresponding Methylprednisolone injection reached approximately USD 214 million in the twelve months ending August 2026.
Background and context
- Gland Pharma Limited, founded in 1978, specializes in generic injectable and ophthalmic pharmaceutical products with presence in about 60 countries globally.
- The company operates primarily on a business-to-business (B2B) model and manufactures a variety of sterile injectable dosage forms such as vials, ampoules, pre-filled syringes, lyophilized vials, among others.
Regulatory and governance context
- Approval received under the abbreviated new drug application (ANDA) pathway by USFDA.
- The release contains a forward-looking statements disclaimer noting that actual results could vary due to various factors.
Highlights
- USFDA approval secured for Methylprednisolone Acetate Injectable Suspension USP in multiple vial dosages.
- Product matches Pfizer’s Depo-Medrol reference drug in bioequivalence and therapeutic use.
- Indicated for a wide range of medical conditions including allergic, dermatologic, endocrine, gastrointestinal, hematologic, neoplastic, nervous system, ophthalmic, renal, respiratory, and rheumatic diseases.
- US market sales for this injectable stood at about USD 214 million for the year ending August 2026.
Disclosures
- Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015
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