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news.Onco Therapies, a division of Strides Arcolab's wholly owned subsidiary Agila, has obtained the US Food and Drug Administration's (FDA) approval for its oncology facility in Bengaluru, India.
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Strides‘ oncology facility was established in 2009 and it manufactures injectables, oral products (tablets and softgels) in the oncology domain.
The approval will allow the company to widen its oncology business, globally.
Following the FDA approval, Strides expects to obtain further approvals for abbreviated new drug application (ANDA) related to its oncology products for which filings have already been made.
Recently, the company has also received the FDA approval for its its sterile facility (non-oncology) in Bengaluru, India.
Agila Specialties CEO Venkat Iyer said this approval is a testimony to the standards of quality, compliance and containment practices put in place by Strides.
"With this approval and the recently announced approval for the Sterile Complex, we now look forward to scaling up our specialty business through the launch of specialised products for the US market," Iyer said.