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List of Drug Master Files (DMF) for 14916 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 TERAZOSIN HCL. 2H2O (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
14916
Active
2000-06-12
Complete
2022-12-08
2022-10-21
II
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Looking for Drug Master Files (DMF) for 14916 of Bioindustria Laboratorio Italiano Medicinali Spa

Looking for Drug Master Files (DMF) for 14916 of Bioindustria Laboratorio Italiano Medicinali Spa 1

20

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 TERAZOSIN HCL. 2H2O, with a corresponding US DMF Number 14916.

Remarkably, this DMF maintains an Active status since its submission on June 12, 2000, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 08, 2022, and payment made on October 21, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II

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