01 1Raks Pharma
01 1TRAMADOL HYDROCHLORIDE USP API (PROCESS-2)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-03-19
Pay. Date : 2013-05-21
DMF Number : 27159
Submission : 2013-05-21
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 TRAMADOL HYDROCHLORIDE USP API (PROCESS-2), with a corresponding US DMF Number 27159.
Remarkably, this DMF maintains an Active status since its submission on May 21, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 19, 2014, and payment made on May 21, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
