USFDA issues two observations for Lupin Nagpur facility

Written by Ruchika Sharma Published On 2023-07-13T13:04:09+05:30 | Updated On 13 July 2023 1:04 PM IST

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Mumbai: Lupin has announced the United States Food and Drug Administration (USFDA) has concluded the inspection at the company's Nagpur Oral Solid Dosage Facility with two observations.

USFDA inspected the facility from July 3 to July 11, 2023.

The inspection closed with issuance of a Form-483 with two observations.

An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

"We are confident of addressing the observations raised, and will work with the U.S. FDA to resolve them at the earliest. We uphold quality and compliance issues with utmost importance and remain committed to be compliant with CGMP quality standards across all our facilities," the company stated in a BSE filing.

Medical Dialogues team had earlier reported that the company had received the Establishment Inspection Report (EIR) from the USFDA for its new injectable facility located in Nagpur, India.

Read also: Lupin gets USFDA EIR for Nagpur facility

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the U.S., India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

The Company specializes in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastro-intestinal (GI), central nervous system (CNS), and women’s health areas. The company invested 7.9% of its revenue in research and development in FY23.

Lupin has 15 manufacturing sites, 7 research centers, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology & Pharmaceuticals sector.

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Ruchika Sharma

Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751