01 1Raks Pharma
01 1TRAMADOL HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-10
Pay. Date : 2021-08-06
DMF Number : 23121
Submission : 2009-09-21
Status : Active
Type : II
20
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, with a corresponding US DMF Number 23121.
Remarkably, this DMF maintains an Active status since its submission on September 21, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 10, 2021, and payment made on August 06, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
