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List of Drug Master Files (DMF) for 23437 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Cerbios-Pharma SA (1)

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01 CALCIUM LEVOFOLINATE (1)

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01 Switzerland (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
23437
Active
2010-01-04
Complete
2013-01-09
2012-12-18
II
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Looking for Drug Master Files (DMF) for 23437 of Cerbios Pharma Sa

Looking for Drug Master Files (DMF) for 23437 of Cerbios Pharma Sa 1

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Cerbios Pharma Sa, based in Switzerland, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Cerbios offers CDMO services for HPAPIs, ADCs & recombinant proteins & is active in the field of generic APIs & probiotics (SF68®).

One of their notable products is CALCIUM LEVOFOLINATE, with a corresponding US DMF Number 23437.

Remarkably, this DMF maintains an Active status since its submission on January 04, 2010, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 09, 2013, and payment made on December 18, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II

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