Gland Pharma’s share price witnessed a 6.4% rise on Friday following the company’s announcement that the US Food and Drug Administration (USFDA) has successfully completed its inspection of the Pashamylaram facility in Hyderabad.
Gland Pharma announced in an exchange statement that it has obtained the Establishment Inspection Report (EIR) from the US drug regulator, signifying the conclusion of the inspection process.
The USFDA conducted a pre-market inspection of the Pashamylaram facility from August 23 to 26, 2023, with the aim of assessing the facility’s adherence to the Quality System/Current Good Manufacturing Practice (CGMP) regulations for medical devices set by the USFDA.
The Pashamylaram facility, which became operational in July 2012, began production for the US market in September 2016.
Gland Pharma witnessed a 6.37% increase in its shares, reaching a peak of ₹1,817.15 on the BSE, after the announcement. Trading volume on the exchange increased more than fourfold.
Gland Pharma stands as a major player in the field of injectables, boasting a vast presence in 60 countries worldwide, spanning the US, Europe and Canada.
The company’s predominant operating model is business-to-business (B2B). Its extensive portfolio of injectable products includes vials, ampoules, prefilled syringes, lyophilized vials, dry powders, infusions, oncology treatments and ophthalmic solutions.
In the July-September quarter of the fiscal year 2023-24, the company experienced a 19.56% year-on-year decline in its consolidated net profit, amounting to ₹194 crore, compared to ₹241.2 crore recorded in the same period a year earlier. On the contrary, its revenue for Q2 of FY24 showed a significant increase, reaching ₹1,373.4 crore, reflecting a growth of 31.52% from the previous year. ₹1,044.4 crores.
The company disclosed last week that it has obtained provisional approval from the USFDA for the Angiotensin II Injection, 2.5 mg/mL Single Unit Vial. This injection is intended for the treatment of low blood pressure in adults.
Shares of Gland Pharma closed 2.88% higher at ₹1,757 per piece, against previous close at ₹1,707 per share.
Updated: 24 Nov 2023, 16:29 IST