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Pashamylaram is a village located in Patancheru mandal of Medak district in Telangana, India.
This certification specifically covers the facility's production of aseptically prepared powder for injection, infusion, and inhalation.
This GMP certificate is crucial for Gland Pharma as it pertains to marketing authorizations that list manufacturers located outside of the European Economic Area (EEA), allowing their products to be marketed within Denmark and potentially other EEA countries.
Gland Pharma is 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 has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions. The company also pioneered heparin technology in India.
The company's consolidated net profit declined 3.06% to Rs 186.54 crore as net sales fell by 7.32% to Rs 1424.91 crore in Q4 FY25 as compared with Q4 FY24.
The scrip had gained 0.89% to end at Rs 1859.05 on the BSE on Friday.
Gland Pharma Ltd is up for a fifth straight session today. The stock is quoting at Rs 1781.7, up 0.08% on the day as on 12:44 IST on the NSE. The benchmark NIFTY is up around 0.62% on the day, quoting at 25402.2. The Sensex is at 83287.99, up 0.64%. Gland Pharma Ltd has gained around 16.61% in last one month.
Meanwhile, Nifty Pharma index of which Gland Pharma Ltd is a constituent, has gained around 0.94% in last one month and is currently quoting at 21804.8, down 0.35% on the day. The volume in the stock stood at 1.35 lakh shares today, compared to the daily average of 1.72 lakh shares in last one month.
The PE of the stock is 26.95 based on TTM earnings ending March 25.
The inspection concluded with three Form 483 observations, which the company clarified were procedural in nature. The firm stated that these are not repeated observations and are unrelated to data integrity. The company intends to submit the required corrective and preventive actions (CAPA) to the USFDA within the stipulated timeline.