Strides Arcolab's penicillin sterile manufacturing site in Bangalore has been classified as acceptable by the US FDA for manufacturing sterile products for the US market. The facility was approved with no FDA-483 observations.
Arun Kumar, vice chairman and Group CEO, Strides Arcolab stated that the US FDA approval of the penicillin sterile facility is an important milestone for the company's US strategy and will support important product submissions with the FDA.
The penicillin sterile facility in Bangalore manufactures sterile injectables in dry powder vials. The plant supports important current and future submissions for the US market.
Strides is one of India's largest exporters of branded generic pharmaceutical products. It is engaged in the production of pharmaceuticals formulations in various dosage forms, including capsules, tablets, liquid injectables and is one of the world's top five manufacturers of softgel capsules. It also has the only globally dedicated soft gel facility for hormones.
In addition, Strides undertakes contract research and the manufacturing of specialty chemicals for various multinational companies. It has a major presence in various developing countries in Africa, Latin America and Asia as well as in developed markets such as the US, Canada and part of Europe. Further, it is one of the largest Indian suppliers of institutionally funded aid projects and is an approved supplier to the World Bank, the African Development Bank and UNICEF, amongst others.