01 1Orchid Pharma
01 1RISEDRONATE SODIUM
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-09-21
Pay. Date : 2014-05-20
DMF Number : 25768
Submission : 2012-03-01
Status : Active
Type : II
20
Orbion Pharmaceuticals Private 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 RISEDRONATE SODIUM, with a corresponding US DMF Number 25768.
Remarkably, this DMF maintains an Active status since its submission on March 01, 2012, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 21, 2014, and payment made on May 20, 2014, indicating their dedication to facilitating drug approvals, Categorized as Type II
