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List of Drug Master Files (DMF) for 27547 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Arevipharma (1)

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01 BUPRENORPHINE (1)

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01 Germany (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
27547
Active
2013-09-23
Complete
2014-06-23
2013-09-30
II
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Looking for Drug Master Files (DMF) for 27547 of Arevipharma Gmbh

Looking for Drug Master Files (DMF) for 27547 of Arevipharma Gmbh 1

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Arevipharma Gmbh, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is BUPRENORPHINE, with a corresponding US DMF Number 27547.

Remarkably, this DMF maintains an Active status since its submission on September 23, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 23, 2014, and payment made on September 30, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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