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Lupin gets EIR from USFDA for Pithampur facility unit


Lupin gets EIR from USFDA for Pithampur facility unit

Mumbai: Through a recent press release Drug firm Lupin recently announced the receipt of the Establishment Inspection Report (EIR) for its Pithampur (Unit 3) facility in Madhya Pradesh from the US health regulator. The inspection at the site was conducted between June 12, 2017, and June 16, 2017.

This was a Pre-approval inspection for Albuterol Sulfate Inhalation product. Lupin’s Pithampur (Unit 3) facility manufactures Dermatological Products, Dry Product Inhalers and Metered Dose Inhalers.

Commenting on the development, Nilesh Gupta, Managing Director, Lupin said, “The receipt of the EIR for our Pithampur Unit 3 is an encouraging development. This is a validation of our commitment to maintaining the highest standards in quality and compliance across our facilities.”

Read Also: Lupin gets 22 observations for MP plant

The US Food and Drug Administration (USFDA) issues an EIR to an establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection.

Lupin is a pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally.

Read Also: Lupin launches Nystatin and Triamcinolone Acetonide in the US market



Source: with inputs
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