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List of Drug Master Files (DMF) for 15321 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Bioindustria L.I.M. Spa (1)

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01 PRAZOSIN HYDROCHLORIDE BULK SUBSTANCE (1)

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01 Italy (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
15321
Active
2001-02-28
Complete
2018-12-27
2017-12-11
II
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Looking for Drug Master Files (DMF) for 15321 of Bioindustria Laboratorio Italiano Medicinali Spa

Looking for Drug Master Files (DMF) for 15321 of Bioindustria Laboratorio Italiano Medicinali Spa 1

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Bioindustria Laboratorio Italiano Medicinali Spa, based in Italy, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Production of small & large volume I.V. Solutions// Generic Drug Products// APIs// GMP certified.

One of their notable products is PRAZOSIN HYDROCHLORIDE BULK SUBSTANCE, with a corresponding US DMF Number 15321.

Remarkably, this DMF maintains an Active status since its submission on February 28, 2001, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 27, 2018, and payment made on December 11, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II

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