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

By Gareth Macdonald contact

- Last updated on GMT


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


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.

Related news

Show more

Related products

show more

Integrated Solutions for Accelerated Time to Market

Integrated Solutions for Accelerated Time to Market

Piramal Pharma Solutions | 08-Jun-2021 | Technical / White Paper

Facing capacity constraints? Lock in your program now! With 14 sites around the world providing diverse services ranging from discovery to drug substance...

Transforming Clinical Development

Transforming Clinical Development

PerkinElmer | 01-Jun-2021 | Technical / White Paper

The estimated cost of bringing a drug to market in the U.S. according to JAMA is $1 billion.1 The extreme cost of clinical trials urge biopharmaceutical,...

Vaccine Innovation in the Era of COVID19

Vaccine Innovation in the Era of COVID19

Covance Patient Safety | 01-Oct-2020 | Sponsored Link

During this time of worldwide crisis, there is an increasing demand for the acceleration of a vaccination for COVID19. Regardless of the great recent advancements...

Lactium, your ally to manage day to day stress

Lactium, your ally to manage day to day stress

Ingredia | 27-Aug-2020 | Product Presentation

Stress has been called the ‘health epidemic of the 21st century’ by the World Health Organization. Increasingly, consumers are looking for safe, reliable...

Related suppliers

Follow us


View more