01 1Formosa Laboratories
01 1SEVELAMER HYDROCHLORIDE
01 1Taiwan
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-10
Pay. Date : 2013-08-29
DMF Number : 22631
Submission : 2009-03-16
Status : Active
Type : II
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Formosa Laboratories Inc, based in Taiwan, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
One of their notable products is SEVELAMER HYDROCHLORIDE, with a corresponding US DMF Number 22631.
Remarkably, this DMF maintains an Active status since its submission on March 16, 2009, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 10, 2013, and payment made on August 29, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II
