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01 1ORGANICA Feinchemie GmbH Wolfen

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PharmaCompass

Looking for Drug Master Files (DMF) for 19601 of Weylchem Organica Gmbh

Looking for Drug Master Files (DMF) for 19601 of Weylchem Organica Gmbh 1

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Weylchem Organica Gmbh, based in Germany, is a pharmaceutical company.

One of their notable products is INDOCYANINE GREEN DRUG SUBSTANCE, with a corresponding US DMF Number 19601.

Remarkably, this DMF maintains an Active status since its submission on July 13, 2006, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of December 05, 2021, and payment made on November 30, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II