Axplora is your partner of choice for complex APIs.
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01 1Axplora
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01 1METHYLENE BLUE USP
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01 1Germany
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01 1Active
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01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-26
Pay. Date : 2023-09-26
DMF Number : 32900
Submission : 2023-09-21
Status : Active
Type : II
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Pharmazell Gmbh, based in Germany, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Axplora is your partner of choice for complex APIs.
One of their notable products is METHYLENE BLUE USP, with a corresponding US DMF Number 32900.
Remarkably, this DMF maintains an Active status since its submission on September 21, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 26, 2023, and payment made on September 26, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II