Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
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01 1Seqens
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01 14-PHENYLBUTYRIC ACID SODIUM SALT
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01 1France
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01 1Active
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01 1Complete
Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
GDUFA
DMF Review : Complete
Rev. Date : 2020-12-12
Pay. Date : 2020-12-08
DMF Number : 9716
Submission : 1992-06-08
Status : Active
Type : II
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Cu Chemie Uetikon Gmbh, based in France, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Seqens is an integrated global leader in pharmaceutical solutions & specialty ingredients, & custom-made solutions to our customers.
One of their notable products is 4-PHENYLBUTYRIC ACID SODIUM SALT, with a corresponding US DMF Number 9716.
Remarkably, this DMF maintains an Active status since its submission on June 08, 1992, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 12, 2020, and payment made on December 08, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II