Shilpa Medicare's wholly owned subsidiary, Shilpa Pharma Lifesciences, has successfully passed an inspection audit conducted by the US Food and Drug Administration (FDA) at its API manufacturing facility in Raichur, India.
The inspection, which was conducted between March 10–14, is the second consecutive clean inspection of the facility, with no 483 observations made during the four day period.
The 958,000 sqft Unit-2 facility is responsible for the manufacture of active pharmaceutical ingredients (APIs), including generic oncological therapeutics.
Shilpa's Raichur site has expertise in isolation, purification and separation techniques, as well as asymmetric synthesis, chiral technology, reduction reactions and customised synthesis.
It is part of a broader network of seven facilities, which have biologic manufacturing, fill-finish and large-scale solid dose drug substance production capabilities.
Through the FDA's approval, Shilpa Pharma Lifesciences will be able to provide a commercial supply of oncology APIs for US patient population.
"We are delighted that our Unit-2 API facility has passed its second consecutive FDA inspection with no observations," noted Vishnukant C. Bhutada, Managing Director of Shilpa Medicare.
"This achievement further reinforces our dedication to providing our customers with high-quality R&D, API and finished dose manufacturing solutions."
Unit-2 has capacity for 520 KL and supports more than 250 customers across 25 APIs and part of CDMO offerings.