MedPath

Gland Pharma Secures USFDA Approval for Acetaminophen Injection for Pain Management

• Gland Pharma has received USFDA approval for Acetaminophen Injection (10 mg/mL) in 500mg/50mL and 1000mg/100mL bag formulations for pain management.

• The injectable product is indicated for mild to moderate pain management in patients 2 years and older, and for moderate to severe pain when used with opioid analgesics.

• With US sales of approximately $55 million for the twelve months ending February 2025, Gland Pharma plans to launch the product through a marketing partner soon.

Hyderabad-based Gland Pharma Limited has secured approval from the United States Food and Drug Administration (USFDA) for its Acetaminophen Injection, 10 mg/mL, available in 500mg/50mL and 1000mg/100mL bag formulations.
The injectable formulation has been confirmed as bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Acetaminophen Injection manufactured by B. Braun Medical, Inc. This approval strengthens Gland Pharma's position in the injectable pharmaceuticals market in the United States.

Therapeutic Applications and Market Potential

The newly approved Acetaminophen Injection is indicated for multiple pain management scenarios, including:
  • Management of mild to moderate pain in adult and pediatric patients 2 years and older
  • Treatment of moderate to severe pain with adjunctive opioid analgesics in adult and pediatric patients 2 years and older
According to IQVIA data, the product recorded approximately US $55 million in sales for the twelve-month period ending February 2025 in the United States market, indicating significant commercial potential for Gland Pharma's generic version.

Commercialization Strategy

Gland Pharma has announced plans to launch the Acetaminophen Injection through its marketing partner in the near future. This approach aligns with the company's established strategy of leveraging partnerships for market access in the competitive US pharmaceutical landscape.
The approval comes as part of Gland Pharma's ongoing efforts to expand its injectable product portfolio in the US market. The company, which specializes in generic injectable formulations, has been steadily building its presence in the US pharmaceutical sector through strategic approvals and launches.

Company Background

Gland Pharma Limited is a generic injectable-focused pharmaceutical company based in Hyderabad, India. The company has established itself as a significant player in the development and manufacturing of injectable formulations, with a growing presence in international markets, particularly the United States.
This approval follows other recent regulatory successes for the company, including USFDA approval for Phytonadione Injectable Emulsion USP, 10 mg/mL Single Dose Ampules, which was also deemed bioequivalent and therapeutically equivalent to Hospira, Inc.'s Vitamin K1 Injectable Emulsion USP (10 mg/mL).
Subscribe Icon

Stay Updated with Our Daily Newsletter

Get the latest pharmaceutical insights, research highlights, and industry updates delivered to your inbox every day.

Related Topics

Alembic Pharmaceuticals Receives FDA Approval for Pantoprazole Sodium Injection to Treat GERD

Alembic Pharmaceuticals has secured final USFDA approval for Pantoprazole Sodium for Injection (40 mg/vial), therapeutically equivalent to Wyeth's Protonix I.V. for Injection.
The approved injection is indicated for treating gastroesophageal reflux disease (GERD) with a history of erosive esophagitis in adults for up to 10 days, as well as pathological hypersecretion conditions including Zollinger-Ellison Syndrome.

Biocon Pharma Secures FDA Approval for Norepinephrine Bitartrate Injection for Acute Hypotension

Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, has received FDA approval for Norepinephrine Bitartrate Injection USP, used to raise blood pressure in adults with acute hypotension.
The approved product is packaged as a 4 mg/4 mL (1 mg/mL) single-dose vial and serves as a critical treatment in emergency medical and intensive care settings.

Avenacy Expands Injectable Antibiotic Portfolio with Launch of Five Critical Products in U.S. Market

Avenacy has launched five injectable antibiotic products in the U.S. market, representing combined annual sales of approximately $175 million and strengthening the company's position in the generic injectables sector.
The newly launched portfolio includes Ampicillin, Ampicillin-Sulbactam, Nafcillin, Penicillin G Potassium, and Piperacillin-Tazobactam injections, all featuring specialized packaging designed to enhance medication safety.

Glenmark Launches Generic Epinephrine Injection with 180-Day Exclusivity

Glenmark Pharmaceuticals has launched a generic version of Epinephrine Injection USP (10 mg/10 mL) Multiple-Dose Vial, securing 180 days of competitive generic therapy exclusivity.
The product is bioequivalent to BPI Labs' reference drug and enters a market with annual sales of approximately $42.7 million as of December 2024.

Gland Pharma Receives US FDA Approval for Phytonadione Injectable Emulsion

Gland Pharma has secured US FDA approval for its phytonadione injectable emulsion, a generic version of vitamin K1 injectable emulsion.
The drug is indicated for treating coagulation disorders resulting from vitamin K deficiency or interference with vitamin K activity.

Aurobindo Pharma's Eugia Pharma Receives USFDA Approval for Generic Pazopanib Tablets

Eugia Pharma Specialities, a subsidiary of Aurobindo Pharma, has secured USFDA approval to manufacture and market Pazopanib Tablets (200 mg) in the US.
The generic drug is therapeutically equivalent to Novartis' Votrient and is indicated for advanced Renal Cell Carcinoma and Soft Tissue Sarcoma after chemotherapy.

Gland Pharma Receives US FDA Approval for Latanoprost Ophthalmic Solution

Gland Pharma has received US FDA approval for Latanoprost Ophthalmic Solution, 0.005% (2.5 mL Fill), a generic equivalent to Xalatan.
The ophthalmic solution is indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

Guangzhou Baiyunshan Receives Approval for Generic Drug

Guangzhou Baiyunshan has secured approval for its generic drug, marking a significant milestone for the company.
The approval is expected to enhance patient access to a cost-effective treatment option.

Aurobindo Pharma Gains US FDA Approval for Cephalexin Antibiotic Tablets

Aurobindo Pharma has received US FDA approval to manufacture and market Cephalexin Tablets USP in 250 mg and 500 mg dosages, used to treat various infections.
The approved tablets are bioequivalent and therapeutically equivalent to Keflet tablets, ensuring similar efficacy and safety profiles for patients.

Lupin Receives FDA Approval for Generic Bumetanide Injection

Lupin has secured FDA approval for its bumetanide injection, available in single and multiple-dose vials, offering a generic alternative to Validus Pharmaceuticals' Bumex.
The bumetanide injection is indicated for treating edema linked to congestive heart failure, hepatic, and renal diseases, including nephrotic syndrome.

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy