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List of Drug Master Files (DMF) for 20759 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 CKD Bio Corporation (1)

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01 ACARBOSE, NON-STERILE BULK DRUG SUBSTANCE (1)

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01 South Korea (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
20759
Active
2007-07-31
Complete
2013-03-15
2013-02-26
II
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Looking for Drug Master Files (DMF) for 20759 of Ckd Bio Corp

Looking for Drug Master Files (DMF) for 20759 of Ckd Bio Corp 1

20

Ckd Bio Corp, based in South Korea, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ACARBOSE, NON-STERILE BULK DRUG SUBSTANCE, with a corresponding US DMF Number 20759.

Remarkably, this DMF maintains an Active status since its submission on July 31, 2007, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 15, 2013, and payment made on February 26, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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