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List of Drug Master Files (DMF) for 26984 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Recipharm AB (1)

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01 DEXMEDETOMIDINE HCL (1)

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01 Sweden (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
26984
Active
2013-03-12
Complete
2014-09-17
2014-04-09
II
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Looking for Drug Master Files (DMF) for 26984 of Edmond Pharma Srl

Looking for Drug Master Files (DMF) for 26984 of Edmond Pharma Srl 1

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Edmond Pharma Srl, based in Sweden, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Recipharm has the brightest minds in the CDMO industry, from early development to commercial manufacturing.

One of their notable products is DEXMEDETOMIDINE HCL, with a corresponding US DMF Number 26984.

Remarkably, this DMF maintains an Active status since its submission on March 12, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 17, 2014, and payment made on April 09, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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