US FDA issues observations on Lupin Pithampur plant

Pharmaceutical company Lupin said that the US food and Drug administration has issued six observations after an inspection at its Pithampur manufacturing unit.

The inspection was conducted between 14th and 25th January said the company.

All companies are supposed to observe good manufacturing practices issued by the US FDA when producing food and drugs meant for the US market.

Observations are typically issued when inspectors find discrepancies in the practices and infrastructure at the inspected facility.

Companies are supposed to work with the US FDA to address the concerns expressed in the observations and resolve them. Failure to resolve the concerns can lead to further complications, including an import ban by the US FDA on items produced at that facility.

Lupin did not give details about the kind of observations that were made. However, it said it was “confident of addressing the observations satisfactorily.”

Lupin develops and distributes generic formulations, biotechnological products and APIs worldwide.

The drug maker holds the top spot in the Anti-TB segment, in addition to being a significant player in the Cardiovascular, Asthma, Pediatric, CNS (Central Nervous System), GI (Gastrointestinal), Anti-infective, NSAID (nonsteroidal anti-inflammatory drug) and Diabetology segments.

According to Bloomberg, Lupin is the 8th largest generic pharmaceutical company in terms of revenue, globally.

The company made total sales of Rs 155 billion and net profit of Rs 13.93 billion during the 2018 financial year.

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