01 1Alkem Laboratories
01 1TAPENTADOL HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-03-01
Pay. Date : 2012-11-08
DMF Number : 26519
Submission : 2012-10-23
Status : Active
Type : II
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Alkem Laboratories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is TAPENTADOL HYDROCHLORIDE, with a corresponding US DMF Number 26519.
Remarkably, this DMF maintains an Active status since its submission on October 23, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 01, 2013, and payment made on November 08, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
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