01 1Apotex Pharmachem
01 1LUBIPROSTONE
01 1Canada
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2018-04-27
Pay. Date : 2018-03-29
DMF Number : 31275
Submission : 2017-01-31
Status : Active
Type : II
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Apotex Pharmachem India Pvt Ltd, based in Canada, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
One of their notable products is LUBIPROSTONE, with a corresponding US DMF Number 31275.
Remarkably, this DMF maintains an Active status since its submission on January 31, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 27, 2018, and payment made on March 29, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
