01 1Ind Swift Laboratories Limited
01 1ACAMPROSATE CALCIUM USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-07
Pay. Date : 2013-02-15
DMF Number : 21481
Submission : 2008-03-24
Status : Active
Type : II
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Synthimed Labs Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from EDQM and WHO-GMP.
One of their notable products is ACAMPROSATE CALCIUM USP, with a corresponding US DMF Number 21481.
Remarkably, this DMF maintains an Active status since its submission on March 24, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 07, 2013, and payment made on February 15, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
