01 1Hikal
01 1ONDANSETRON USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2021-08-17
Pay. Date : 2021-08-12
DMF Number : 18829
Submission : 2005-09-03
Status : Active
Type : II
20
Hikal Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Partnering with Pharmaceutical, Life Sciences, Biotech & Specialty Chemicals Companies to deliver APIs, Intermediate & R&D Services.
One of their notable products is ONDANSETRON USP, with a corresponding US DMF Number 18829.
Remarkably, this DMF maintains an Active status since its submission on September 03, 2005, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 17, 2021, and payment made on August 12, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II
