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List of Drug Master Files (DMF) for 28629 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Alkaloids Corporation (1)

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01 METHSCOPOLAMINE BROMIDE (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
28629
Active
2014-09-08
Complete
2015-10-06
2015-03-25
II
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Looking for Drug Master Files (DMF) for 28629 of Alkaloids Corp

Looking for Drug Master Files (DMF) for 28629 of Alkaloids Corp 1

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Alkaloids Corp, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for Identification, Development, Production & Distribution of potent Phytochemicals and Botanical extracts

One of their notable products is METHSCOPOLAMINE BROMIDE, with a corresponding US DMF Number 28629.

Remarkably, this DMF maintains an Active status since its submission on September 08, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 06, 2015, and payment made on March 25, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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