01 1Hikal
01 1SITAGLIPTIN PHOSPHATE ANHYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-11-22
Pay. Date : 2024-09-27
DMF Number : 34734
Submission : 2020-03-28
Status : Active
Type : II
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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 SITAGLIPTIN PHOSPHATE ANHYDRATE, with a corresponding US DMF Number 34734.
Remarkably, this DMF maintains an Active status since its submission on March 28, 2020, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of November 22, 2024, and payment made on September 27, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
