01 1Ind Swift Laboratories Limited
01 1ROPINIROLE HYDROCHLORIDE USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-01-17
Pay. Date : 2023-01-13
DMF Number : 18564
Submission : 2005-07-30
Status : Active
Type : II
20
Synthimed Labs Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from EDQM and WHO-GMP.
One of their notable products is ROPINIROLE HYDROCHLORIDE USP, with a corresponding US DMF Number 18564.
Remarkably, this DMF maintains an Active status since its submission on July 30, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 17, 2023, and payment made on January 13, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
