01 1Porton Pharma Solutions
01 1ISAVUCONAZONIUM SULFATE API, NON-STERILE DRUG SUBSTANCE
01 1China
01 1Active
01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2024-09-25
Pay. Date : 2024-08-28
DMF Number : 39012
Submission : 2023-11-10
Status : Active
Type : II
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Porton Pharma Solutions Ltd, based in China, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Porton Pharma Solutions: Value creation via innovation & discovery through technical platforms.
One of their notable products is ISAVUCONAZONIUM SULFATE API, NON-STERILE DRUG SUBSTANCE, with a corresponding US DMF Number 39012.
Remarkably, this DMF maintains an Active status since its submission on November 10, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 25, 2024, and payment made on August 28, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
