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List of Drug Master Files (DMF) for 27983 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Apotex Pharmachem (1)

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01 FINGOLIMOD HYDROCHLORIDE (1)

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01 Canada (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
27983
Active
2014-03-28
Complete
2014-08-07
2014-03-28
II
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Looking for Drug Master Files (DMF) for 27983 of Apotex Pharmachem India Pvt Ltd

Looking for Drug Master Files (DMF) for 27983 of Apotex Pharmachem India Pvt Ltd 1

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

One of their notable products is FINGOLIMOD HYDROCHLORIDE, with a corresponding US DMF Number 27983.

Remarkably, this DMF maintains an Active status since its submission on March 28, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of August 07, 2014, and payment made on March 28, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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