01 1Natco Pharma
01 1ERLOTINIB HYDROCHLORIDE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2015-06-09
Pay. Date : 2015-05-27
DMF Number : 21786
Submission : 2008-07-11
Status : Active
Type : II
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Natco Pharma 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 ERLOTINIB HYDROCHLORIDE, with a corresponding US DMF Number 21786.
Remarkably, this DMF maintains an Active status since its submission on July 11, 2008, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of June 09, 2015, and payment made on May 27, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II
