Lupin
Lupin's Goa facility was inspected by the US drug regulator between November 10 - 21 and was issued a form 483 with seven observations.
The company said in its filing that it will address the observations and respond to the USFDA within the stipulated timeframe and remain committed to be compliant with the CGMP standards across facilities.
Shares of Lupin have gained 5% in the last one month, but are down 14% in 2025 so far.
Shilpa Medicare
The USFDA inspected Shilpa Medicare's Unit IV Jadcherla facility for a 10-day period that concluded on November 21.
Post the inspection, the USFDA issued a form 483 with eight observations, none of which have been categorized as a repeat observation.
Shilpa Medicare's Jadcherla facility is capable of manufacturing, packaging, testing, storage and distribution of sterile injectables, oral tablets and Capsules, and is supplying to US, Europe and other markets across the globe.
US sales from this facility was less than 1% of the overall figure, while the facility contributed to less than 5% of the overall topline, the drugmaker stated in its filing.
Shares of Shilpa Medicare are down 3.5% in the last one month and are also down 14% so far in 2025.
Natco Pharma
The drugmaker's API manufacturing facility in Chennai was inspected by the regulator between November 17 to November 21 and was issued a form 483 with seven observations on conclusion.
In its exchange filing, Natco Pharma stated that these observations are procedural in nature and will be addressed comprehensively.
"The company remains committed to being cGMP compliant and in supplying high-quality products to its customers and patients globally," the filing stated.
Shares of Natco Pharma are up 4.5% in the last one month but have been underperformers this year, having declined 40% so far in 2025.
Alkem Laboratories
The GMP inspection conducted by the Ministry of Health, Armenia, at the company's manufacturing facility in Sikkim, between November 21-22, concluded with no critical or major observation, according to Alkem's filing.
The stock has gained 3% in the last one month, and a similar quantum on a year-to-date basis as well.
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