01 1Hikal
01 1GABAPENTIN USP
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-01-18
Pay. Date : 2012-12-14
DMF Number : 16060
Submission : 2002-07-24
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 GABAPENTIN USP, with a corresponding US DMF Number 16060.
Remarkably, this DMF maintains an Active status since its submission on July 24, 2002, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 18, 2013, and payment made on December 14, 2012, indicating their dedication to facilitating drug approvals, Categorized as Type II
