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List of Drug Master Files (DMF) for 21584 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Cayman Pharma s.r.o (1)

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01 EPOPROSTENOL SODIUM (1)

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01 Czech Republic (1)

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01 Active (1)

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01 Complete (1)

Looking for Drug Master Files (DMF) for 21584 of Cayman Pharma Sro

Looking for Drug Master Files (DMF) for 21584 of Cayman Pharma Sro 1

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Cayman Pharma Sro, based in Czech Republic, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.

They are recognized for Cayman Pharma is Europe's most reliable and versatile source for Prostaglandin APIs//FDA approved.

One of their notable products is EPOPROSTENOL SODIUM, with a corresponding US DMF Number 21584.

Remarkably, this DMF maintains an Active status since its submission on April 28, 2008, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of September 27, 2019, and payment made on September 13, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II

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