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    Strides Pharma gets USFDA approval for Gabapentin capsules

    Medical Dialogues BureauWritten by Medical Dialogues Bureau Published On 2018-10-23T09:10:03+05:30  |  Updated On 23 Oct 2018 9:10 AM IST
    Strides Pharma gets USFDA approval for Gabapentin capsules
    Banglore: Strides Pharmaceutical Science’s step-down wholly-own subsidiary, Strides Pharma Global, Singapore, has received approval for Gabapentin capsules from the United States Food & Drug Administration (US FDA). The product received approval in the first cycle of review of 10 months under the GDUFA II regime.

    The drug will be available in three doses of 100 mg, 300 mg, and 400 mg. The US market for these three doses is $270 million.

    The medicine is a generic version of Neurontin capsules of Pfizer, and is an antiepileptic drug used with other medications to prevent and control seizures. It is also used to relieve nerve pain following shingles, in adults.

    The product will be marketed by Strides Pharma in the US market.

    The company has 78 cumulative ANDA (abbreviated new drug application) filings with US FDA, of which 53 have been approved and 25 are pending approval. Strides Pharma Science (Formerly Strides Shasun) is a pharmaceutical company with a major focus on development and manufacture of IP-led niche finished dosage formulations. It is also among the world's largest manufacturers of soft gelatin capsules.

    Read Also: Fighting Counterfeit Drugs: NITI Aayog, Oracle, Apollo Hospitals Strides Pharma Join Hands
    antiepileptic drugGabapentinNeurontinPfizerStrides PharmaUnited States Food & Drug AdministrationUSFDA

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    Medical Dialogues Bureau
    Medical Dialogues Bureau

      Medical Dialogues Bureau consists of a team of passionate medical/scientific writers, led by doctors and healthcare researchers.  Our team efforts to bring you updated and timely news about the important happenings of the medical and healthcare sector. Our editorial team can be reached at editorial@medicaldialogues.in. Check out more about our bureau/team here

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