The USFDA has inspected Lupin's Mandideep Unit-1 facility from November 14, 2022 to November 23, 2022. 

 

The inspection of the facility resulted in issuance of a Form-483 with eight observations each for the Drug Product facility and API facility at the site.

 

The company is  committed to addressing the observations and will work with the USFDA to resolve these issues at the earliest. The company does not believe that this will have an impact on disruption of supplies or the existing revenues from operations of this facility.

 

The company upholds quality and compliance issues with utmost importance and remains committed to be compliant with cGMP quality standards across all their facilities.

 

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 US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

 

The company enjoys a leadership position in the cardiovascular, anti-diabetic, and respiratory segments and has a significant presence in the anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health areas. Lupin is the third-largest pharmaceutical company in the US by prescription. The company invested 8.7% of its revenue in research and development in FY22.

 

Lupin has 15 manufacturing sites, 7 research centers, more than 20,000 professionals working globally, and has been consistently recognized as a ‘Great Place to Work’ in the Biotechnology and Pharmaceuticals sector.