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    Strides Pharma subsidiary gets USFDA nod for drug product capabilities

    Strides Pharma subsidiary gets USFDA nod for drug product capabilities

    Strides Pharma subsidiary gets USFDA nod for drug product capabilities
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    By CNBCTV18.COM IST (Published)


    Strides Pharma's subsidiary received an Establishment Inspection Report from the USFDA. Will this spark a change in fortunes for the worst performing stock on the Nifty Pharma index?

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    Shares of drug maker Strides Pharma (STAR) gained on Thursday after the company's subsidiary Stelis Biopharma received an Establishment Inspection Report (EIR) from the USFDA for its Drug Products facility.
    The stock was trading near the day's high at Rs 333.8, up 1 percent. The stock has nearly halved from its 52-week high in September last year and is the worst performer on the Nifty Pharma index over the last 12 months.
    The drug regulator conducted the inspection at the company's flagship manufacturing site in Bengaluru. The outcome follows a Pre-Approved Inspection at Stelis' flagship manufacturing facility for several product submissions.
    Strides says that the EIR paves the way for commercial services revenue from the site in the next two quarters after its partners receive the respective product approvals. The facility offers capabilities across all injectable formats, the company said in an exchange filing.
    "We have had an exciting year so far, and we continue to deliver even better financial outcomes as we accelerate and build on the opportunities in the Global CDMO landscape," Strides founder Arun Kumar was quoted as saying.
    The USFDA nod also comes within two months of the company receiving the EU-GMP approval in June 2022. "While these two outcomes validate our GMP systems and Global Quality fabric, it fast-tracks our ability to close out on the impending manufacturing services agreements for the precommercial revenues," Kumar said.
    Strides' flagship facility also houses microbial and mammalian drug substance capabilities. While the microbial capabilities are already commissioned, the mammalian ones will be available to partners later this month. The management also said that Stelis continues to build on its clientele with global partnerships and onboarding of new programs on the drug substance and drug product side.
    The news also follows peer Biocon's update where it received multiple observations for its facilities in Bangalore and Malaysia.
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