01 1GLAND CHEMICALS PRIVATE LIMITED
01 1PEMETREXED DISODIUM 2.5 HYDRATE
01 1India
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2016-03-02
Pay. Date : 2016-02-24
DMF Number : 25399
Submission : 2011-11-03
Status : Active
Type : II
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Gland Chemicals Private 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 PEMETREXED DISODIUM 2.5 HYDRATE, with a corresponding US DMF Number 25399.
Remarkably, this DMF maintains an Active status since its submission on November 03, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of March 02, 2016, and payment made on February 24, 2016, indicating their dedication to facilitating drug approvals, Categorized as Type II
