Gland Pharma gets 2 USFDA observations for Dundigal facility

Written By :  Ruchika Sharma
Medically Reviewed By :  Dr. Kamal Kant Kohli
Published On 2024-07-25 09:58 GMT   |   Update On 2024-07-25 09:58 GMT

Telangana: Gland Pharma has announced that the United States Food and Drug Administration (US FDA) has concluded a surprise inspection of the Company's Dundigal Facility at Hyderabad for Good Manufacturing Practices (GMP) with two 483 Observations.

The inspection was conducted between 22nd July, 2024 and 25th July, 2024
"These observations are procedural in nature. The corrective and preventive actions for these observations will be submitted to the US FDA within the stipulated period. The observations issued are neither repeated observations nor related to data integrity," Gland Pharma stated.
Advertisement

Gland Pharma was established in 1978 in Hyderabad and has grown over the years from a contract manufacturer of small-volume liquid parenteral products to become 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 develops, manufactures, and markets sterile injectables. It has a wide range of injectables, including vials, ampoules, pre-filled syringes, lyophilized vials, dry powders, infusions, oncology, and ophthalmic solutions.

Read also: Gland Pharma promoter Fosun divests 6 percent stake for Rs 1,754 crore

Tags:    

Disclaimer: This site is primarily intended for healthcare professionals. Any content/information on this website does not replace the advice of medical and/or health professionals and should not be construed as medical/diagnostic advice/endorsement/treatment or prescription. Use of this site is subject to our terms of use, privacy policy, advertisement policy. © 2024 Minerva Medical Treatment Pvt Ltd

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News