Pharma major Lupin Limited announced today that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Mandideep Unit-2 manufacturing facility located in Madhya Pradesh under the “No Action Indicated” classification.
The plant was inspected from August 7-11. The “No Action Indicated” (NAI) classification indicates that no objectionable conditions or practices were found during the inspection.
The positive outcome of the inspection enables Lupin to continue supplying pharmaceutical products from the Mandideep facility to the U.S., which is the company’s largest market. The facility manufactures a range of Lupin’s generic oral solids and injectable products.
Lupin has been making significant investments in enhancing its quality and regulatory compliance standards across its manufacturing network. The company has stepped up its efforts to upgrade and modernize its facilities and quality control labs, implement new technologies and automation, and strengthen training for its employees.
This latest EIR provides validation of Lupin’s focus on compliance, and indicates the progress the company has made in resolving previous FDA inspections observations across its facilities.
Lupin is the third largest pharmaceutical company in the U.S. by prescriptions and has a significant presence in cardiovascular, anti-diabetic, respiratory and other therapeutic areas. The company has a global footprint across 100+ markets including the U.S., India, South Africa, Asia Pacific, Latin America, Europe and Middle East regions.
Headquartered in Mumbai, Lupin develops and markets a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs). The company is recognized as one of the leading generics players in the U.S. pharmaceuticals market.
The company has 15 manufacturing sites, 7 research centers and over 20,000 professionals working globally.