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List of Drug Master Files (DMF) for 19528 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Curia (1)

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01 BUDESONIDE STERILE MICRONIZED (1)

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01 U.S.A (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
19528
Active
2006-06-14
Complete
2015-10-07
2015-09-24
II
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Looking for Drug Master Files (DMF) for 19528 of Curia Spain Sau

Looking for Drug Master Files (DMF) for 19528 of Curia Spain Sau 1

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Curia Spain Sau, based in U.S.A, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Curia- A partner for the pharma and biotech industries to improve patient outcomes & quality of life.

One of their notable products is BUDESONIDE STERILE MICRONIZED, with a corresponding US DMF Number 19528.

Remarkably, this DMF maintains an Active status since its submission on June 14, 2006, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 07, 2015, and payment made on September 24, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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