01 1SMS Pharmaceuticals
01 1RANITIDINE HYDROCHLORIDE USP (PROCESS -2)
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2017-07-11
Pay. Date : 2017-05-31
DMF Number : 31575
Submission : 2017-03-16
Status : Active
Type : II
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Sms Pharmaceuticals 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 RANITIDINE HYDROCHLORIDE USP (PROCESS -2), with a corresponding US DMF Number 31575.
Remarkably, this DMF maintains an Active status since its submission on March 16, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 11, 2017, and payment made on May 31, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
