Lupin addresses FDA queries on Pithampur plant

Pharma major Lupin said that the United States Food and Drug Administration has given it an Establishment Inspection Report (EIR) for its Pithampur facility, which was slapped with five observations in an inspection in October.

The receipt of an EIR is considered good news as it means that the company can now use the facility to manufacture items that are meant to be sold in the US.

Lupin’s Pithampur facility manufactures dermatological products, dry product inhalers and metered dose inhalers.

The inspection at the site was carried out for 10 days between October 8 and October 18 last year.

Lupin had, at the time, said the inspection had led to five observations that were procedural in nature.

Procedural observations are referred to as deficiencies in standard operating procedures in production, testing and hygiene. They are considered relatively easy to address than critical and mildly critical observations.

The inspection of the plant was triggered after the company filed application for the sales of Tiotropium dry powder inhalation drug.

Tiotropium dry powder inhalation drug is sold by Boehringer Ingelheim Pharmaceuticals under the brand Spiriva and is indicated in the treatment of chronic obstructive pulmonary disease (COPD).

It is a patented drug and was approved by the US Food and Drug Administration in 2004. Boehringer Ingelheim Pharmaceuticals is also in a litigation battle against Lupin over Spiriva.

“Receiving the EIR for our Pithampur Unit-3 facility is a very positive development and brings us one step closer to bringing important metered dose inhalers and dry powder inhalers to the market”, said, Nilesh Gupta, Managing Director, Lupin.

Lupin is one of the world’s biggest makers of generic drugs, and sells both branded and generic formulations, biotechnology products and pharmaceutical ingredients globally.

It is the world’s biggest manufacturer of anti-TB medicines and focuses on cardiovascular, diabetology, asthma, paediatric, CNS, GI, anti-infective and NSAID segments of the pharma market.