Lupin says it fixed issue flagged by US FDA during Aurangabad audit

By Gareth Macdonald contact

- Last updated on GMT

iStock/Singh_Lens
iStock/Singh_Lens

Related tags: Pharmacology

Lupin says it has already resolved a problem flagged in a Form 483 issued by US FDA inspectors who visited its Aurangabad manufacturing facility in July. 

The Indian drug manufacturer announced the Form 483 in a filing​ on the Bombay Stock Exchange (BSE) on July 31, describing the single observation listed as “procedural in nature,” adding that it had been corrected during the inspection.

The Aurangabad site produces a range of dosage forms, from tablets and capsules to liquid drug formulations. The facility employs 362 people.

Lupin declined to comment when contacted by in-Pharmatechnologist.com.

Inspections

News of the form 483 follows just days​ after Lupin said its plant in Pithampur, India had passed an inspection by the US Food and Drug Administration (FDA).

Lupin said that inspectors who visited the site on July 24 approved the facility – known as Unit 1 – without making any critical observations.

The site – which is 30km outside the city of Indore – makes active pharmaceutical ingredients (API) and orally administered dosage forms. 

Prior to that, Lupin’s facility in Goa passed​ an inspection by the US regulator.

The Goa facility manufactures oral solid dose and injectable pharmaceutical products for the US market.

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