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

By Gareth Macdonald

- 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.

Related news

Show more

Related products

show more

Increasing the Bioavailability of Oncology Drugs

Increasing the Bioavailability of Oncology Drugs

Content provided by Lonza Small Molecules | 13-Nov-2023 | White Paper

Oral tyrosine kinase inhibitors (TKIs) are a class of cancer drugs that can be highly susceptible to issues with solubility in the gastrointestinal tract

Efficient Freezing & Storage of Biopharmaceuticals

Efficient Freezing & Storage of Biopharmaceuticals

Content provided by Single Use Support | 06-Nov-2023 | White Paper

Various options exist for freezing biopharmaceutical bulk material, but selecting the most effective and efficient approach for each cold chain can be...

Pulmonary Delivery of Orally Inhaled Therapeutics

Pulmonary Delivery of Orally Inhaled Therapeutics

Content provided by Catalent Pharma Solutions | 19-Oct-2023 | Business Advice

New classes and indications of orally inhaled therapeutics are rapidly expanding, with the development pipeline increasingly featuring both large and small...