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    Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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    Aurigene is a global leader in accelerating drug innovation through discovery, development & manufacturing.

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    Midas Pharma provides expertise in developing and supplying APIs, finished products, and intermediates.

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    ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.

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    Mission CDMO team brings reliability, resourcefulness, & responsiveness in executing your development project.

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    Newgen Biotech USA

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    Newgen Biotech USA

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    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 31154

    Submission : 2016-11-10

    Status : Active

    Type : II

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    Newgen Biotech USA

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    Alpha Galactosidase

    About the Company : Newgen Biotech® USA provides a global platform for accessing the highest quality ingredients and blends. We source our products from manufacturing sites that adhere to ISO9001, IS...

    Newgen Biotech® USA provides a global platform for accessing the highest quality ingredients and blends. We source our products from manufacturing sites that adhere to ISO9001, ISO22000, HACCP, HARPC, and GMPs for NSF GMP for US Food, as well as pharmaceutical GMP standards for international companies with different standards from the US. As a well-established, contract manufacturer and distributor, we serve various industries such as Food & Beverage, Human Nutrition, and Cosmetics. Our key manufacturer's products and processes hold over 30 patents, and many of our offerings are certified HALAL, KOSHER, and comply with REACH standards.
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