In early Thursday morning trading, Gland Pharma’s shares jumped to 4.76 percent at Rs 1860 on the BSE following the company’s medication approval from the US Food and medication Administration (USFDA). Phytonadione Injectable Emulsion was approved by the USFDA for the generic medication manufacturer. The vitamin K1 injectable emulsion from Hospira, Inc. is the reference listed drug (RLD) that the product is both bioequivalent and therapeutically equivalent to.
Gland Pharma receives USFDA Approval
The United States Food and Drug Administration (USFDA) has approved Gland Pharma’s Phytonadione Injectable Emulsion USP, 10 mg/mL Single Dose Ampules. The product is both therapeutically and bioequivalent to Hospira, Inc.’s Vitamin K1 Injectable Emulsion USP, 10 mg/mL, which is the reference listed drug (RLD).
This product is recommended for coagulation problems brought on by a lack of vitamin K or interference with its activity. The company anticipates launching this product soon through its marketing partners. For the 12 months ending in September 2024, the product sold about USD 15 million in the US, according to IQVIA.
About the Company
Gland Pharma was established in Hyderabad in 1978 as a modest contract manufacturer and has since grown to become one of the biggest pharmaceutical firms in the world that specializes in injectables. The company uses a business-to-business (B2B) model and has a significant presence in 60 countries, including the US, Europe, Canada, and India. Gland Pharma has a remarkable history of creating, producing, and distributing sterile injectables while upholding strict quality and innovation standards.
The company provides a wide range of products, such as lyophilized vials, ampoules, pre-filled syringes, dry powders, infusions, oncology, and ophthalmic solutions. By providing cutting-edge injectable solutions to answer pressing medical demands, Gland Pharma, an Indian leader in heparin technology, keeps solidifying its standing as a trustworthy partner in international healthcare.
