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news.Strides Arcolab, an India-based exporter of branded generic pharmaceutical products, has announced that its penicillin sterile manufacturing site in Bangalore has been classified as acceptable by the FDA for manufacturing sterile products for the US market.
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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. The facility was approved with no FDA-483 observations.
Arun Kumar, vice chairman and Group CEO of Strides Arcolab, stated that the 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.