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List of Drug Master Files (DMF) for 28458 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Chirogate International (1)

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01 TREPROSTINIL (1)

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01 Taiwan (1)

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01 Active (1)

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01 Complete (1)

28458
Active
2014-09-16
Complete
2015-01-06
2014-07-15
II

Looking for Drug Master Files (DMF) for 28458 of Chirogate International Inc

Looking for Drug Master Files (DMF) for 28458 of Chirogate International Inc 1

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Chirogate International Inc, based in Taiwan, is a pharmaceutical company that stands out with its certifications from FDA.

They are recognized for Chirogate is a professional Prostaglandin manufacturer.

One of their notable products is TREPROSTINIL, with a corresponding US DMF Number 28458.

Remarkably, this DMF maintains an Active status since its submission on September 16, 2014, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 06, 2015, and payment made on July 15, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II

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