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List of Drug Master Files (DMF) for 25892 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 CTX Lifesciences (1)

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01 AMIODARONE HYDROCHLORIDE USP (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
25892
Active
2012-04-09
Complete
2016-05-24
2015-09-11
II
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Looking for Drug Master Files (DMF) for 25892 of Ctx Life Sciences Pvt Ltd

Looking for Drug Master Files (DMF) for 25892 of Ctx Life Sciences Pvt Ltd 1

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Ctx Life Sciences Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is AMIODARONE HYDROCHLORIDE USP, with a corresponding US DMF Number 25892.

Remarkably, this DMF maintains an Active status since its submission on April 09, 2012, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of May 24, 2016, and payment made on September 11, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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