01 1Raks Pharma
01 1SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-08-21
Pay. Date : 2013-06-10
DMF Number : 27189
Submission : 2013-06-14
Status : Active
Type : II
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Raks Pharma Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
One of their notable products is SAXAGLIPTIN HYDROCHLORIDE DIHYDRATE, with a corresponding US DMF Number 27189.
Remarkably, this DMF maintains an Active status since its submission on June 14, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 21, 2013, and payment made on June 10, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
