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Lupin, India's third-largest maker, said it has received five observations from US FDA for its Pithampur Unit-3 facility near Indore.
The company said the observations are all procedural in nature.
Procedural observations are referred to as deficiencies in standard operating procedures (SOPs) in production, testing and hygiene. They are considered to be relatively easier to address.
The inspection at the site was conducted for 10 days between October 8 and 18, 2018.
The pre-approval inspection (PAI) was triggered after the company filed Tiotropium dry powder inhalation (DPI) abbreviated new drug application (ANDA).
Tiotropium DPI is the generic version of German drug maker Boehringer Ingelheim's Spiriva used in treatment of chronic obstructive pulmonary disease (COPD) and asthma. The Spiriva franchise has global sales of 2.83 billion euros, more than half of what is generated in the US.
Lupin filed Para-IV ANDA on Spiriva in Q1FY19, its first DPI filing in the US. Generic Spiriva is part of Lupin's complex portfolio that's expected to help company to beat the pricing pressure in US. Lupin had done clinical trials for the drug.
Shares of Lupin dropped 1.99 percent to end at Rs 877.60 on BSE, while the BSE Healthcare index fell 1.24 percent to 34,349.44 points.
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