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    List of Drug Master Files (DMF) for 20541 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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    Changzhou Qianhong

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    Minakem offers CDMO services for API & HPAPI, generics, regulatory expertise, track record performance & FDA & GMP certifications.

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    01 Changzhou Qianhong (1)

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    01 DALTEPARIN SODIUM (1)

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    CHANGZHOU QIANHONG BIO PHARMA CO LT...

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      DALTEPARIN SODIUM

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      20541
      Active
      2007-03-27
      Complete
      2018-02-22
      2014-07-25
      II
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      Looking for Drug Master Files (DMF) for 20541 of Changzhou Qianhong Bio Pharma Co Ltd

      Looking for Drug Master Files (DMF) for 20541 of Changzhou Qianhong Bio Pharma Co Ltd 1

      20

      Changzhou Qianhong Bio Pharma Co Ltd, based in China, is a pharmaceutical company.

      One of their notable products is DALTEPARIN SODIUM, with a corresponding US DMF Number 20541.

      Remarkably, this DMF maintains an Active status since its submission on March 27, 2007, highlighting commitment to regulatory compliance.

      Their GDUFA DMF Review was successfully complete, with a review date of February 22, 2018, and payment made on July 25, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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