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List of Drug Master Files (DMF) for 27259 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Amino Chemicals (1)

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01 ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE (1)

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01 Malta (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
27259
Active
2013-07-15
Complete
2014-02-12
2013-07-08
II
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Looking for Drug Master Files (DMF) for 27259 of Amino Chemicals Ltd

Looking for Drug Master Files (DMF) for 27259 of Amino Chemicals Ltd 1

20

Amino Chemicals Ltd, based in Malta, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

One of their notable products is ZIPRASIDONE HYDROCHLORIDE MONOHYDRATE, with a corresponding US DMF Number 27259.

Remarkably, this DMF maintains an Active status since its submission on July 15, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 12, 2014, and payment made on July 08, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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