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List of Drug Master Files (DMF) for 32639 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Acebright India Pharma Private Limited (1)

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01 PEMETREXED DISODIUM HEMIPENTA HYDRATE [DRUG SUBSTANCE (NON-STERILE)] (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
32639
Active
2018-02-28
Complete
2019-10-18
2019-07-10
II
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Looking for Drug Master Files (DMF) for 32639 of Acebright India Pharma Private Ltd

Looking for Drug Master Files (DMF) for 32639 of Acebright India Pharma Private Ltd 1

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Acebright India Pharma Private 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 PEMETREXED DISODIUM HEMIPENTA HYDRATE [DRUG SUBSTANCE (NON-STERILE)], with a corresponding US DMF Number 32639.

Remarkably, this DMF maintains an Active status since its submission on February 28, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 18, 2019, and payment made on July 10, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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