Shilpa Medicare has announced that its wholly owned subsidiary, Shilpa Pharma Lifesciences, has successfully completed a U.S. Food and Drug Administration (FDA) inspection at its Unit-2 API manufacturing facility in Raichur, India, with no Form 483 observations issued. The audit, which took place from March 10 to March 14, marks the second consecutive clean inspection for the site.
Located on a 22-acre plot, Unit-2 is the company’s second and largest API manufacturing site and has been operational since 21 March 2008. The facility plays a key role in the company’s broader manufacturing network, which includes seven sites supporting biologic substance manufacturing, fill-finish operations, and large-scale solid dose production. The Raichur site is critical in supplying oncological active pharmaceutical ingredients (APIs) for commercial distribution in the United States.
“This achievement further reinforces our dedication to providing our customers with high-quality R&D, API, and finished dose manufacturing solutions,” said Vishnukant C. Bhutada, Managing Director of Shilpa Medicare.
The FDA audit examined the site’s infrastructure, technical capabilities, and systems for compliance. According to the company, the inspection acknowledged the team’s technical expertise, as well as the quality of systems, documentation, and records maintained at the site.
Shilpa Pharma Lifesciences stated that the facility has a manufacturing capacity of 520 KL and supports more than 250 customers across 25 APIs. The site is also integrated into the company’s contract development and manufacturing organisation (CDMO) service offerings for both generics and innovators.
The completion of this inspection allows the facility to continue uninterrupted support for regulated markets, particularly in the oncology segment in the United States.