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    Neuland Laboratories Ltd

    India
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    Suite 401, 402, 414; InterContinental NY Barclay
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    Virtual BoothNeuland Laboratories- A dedicated 100% API provider.

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    GDUFA

    DMF Review : Complete

    Rev. Date : 2023-09-26

    Pay. Date : 2023-08-28

    DMF Number : 36451

    Submission : 2021-11-06

    Status : Active

    Type : II

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    Looking for Drug Master Files (DMF) for 36451 of Neuland Laboratories Ltd

    Looking for Drug Master Files (DMF) for 36451 of Neuland Laboratories Ltd 1

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    Neuland Laboratories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

    They are recognized for Neuland Laboratories- A dedicated 100% API provider.

    One of their notable products is ARIPIPRAZOLE MONOHYDRATE (STERILE), with a corresponding US DMF Number 36451.

    Remarkably, this DMF maintains an Active status since its submission on November 06, 2021, highlighting commitment to regulatory compliance.

    Their GDUFA DMF Review was successfully complete, with a review date of September 26, 2023, and payment made on August 28, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II

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    • Product listings are provided for informational purposes only. We do not supply or sell any products. Any products that may be covered by patent(s) are supplied solely for uses permitted under Section 107A of the Indian Patents Act and not for commercial sale.