Hyderabad, April 22, 2021: Gland Pharma Limited (BSE: 543245 I NSE: GLAND), a generic injectable focused pharmaceutical company, received approval from the United States Food and Drug Administration (US FDA) for generic Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) Single-Dose Bag for Infusion. 

Generic Foscarnet Sodium Injection is the bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Foscavir^® Injection, 24 mg/mL, of Clinigen Healthcare Limited. With this approval, Gland Pharma secured the first generic offering status in Single-Dose Bag for Infusion. Gland Pharma Limited (Gland Pharma) was granted a Competitive Generic Therapy (CGT) designation for Foscarnet Sodium Injection as it is the “first approved applicant” for such competitive generic therapy, as per US FDA norms and therefore, is eligible for 180 days of CGT exclusivity. This exclusivity will begin only after commercial launch date and as per criteria set out by US FDA.

Gland Pharma is backward integrated with in-house API source for this product.

Foscarnet Sodium Injection is indicated for the treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS). It is also used for the treatment of acyclovir-resistant mucocutaneous herpes simplex virus (HSV) infections in immunocompromised patients. 

The Foscarnet Sodium Injection, 6000 mg/250 mL (24 mg/mL) and its generic equivalents had US sales of approximately USD 28 million for twelve months ending in January 2021, according to IQVIA. 

Gland Pharma intends to supply this product globally and recently launched the product in the Canadian market. Global markets size is estimated to be USD 50 million. 

About Gland Pharma Limited (BSE: 543245, NSE: GLAND) 

Gland Pharma was established in 1978 in Hyderabad, has grown over the years from a contract manufacturer of small volume liquid parenteral products, to become one of the largest and fastest growing 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 have an excellent track record in the development, manufacturing and marketing of complex injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology and ophthalmic solutions and also enjoys the distinction of having pioneered Heparin technology in India. 

Contacts: 

Sampath Kumar Pallerlamudi                                                    Sumanta Bajpayee 

Company Secretary and Compliance Officer                            Vice President – Investor Relations 

investors@glandpharma.com                                                    sumanta.bajpayee@glandpharma.com 

This release may include statements of future expectations and other forward-looking statements based on management's current expectations and beliefs. Actual results may vary materially from those expressed or implied by the statements herein due to changes in economic, business, competitive, technological and/or regulatory factors. Gland Pharma Limited, its directors and any of the affiliates or employee is under no obligation to, and expressly assume any obligation to update any particular forward-looking statement contained in this release.