KEY PRODUCTS
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
01 1Symbiotec Pharmalab
01 1PROGESTERONE USP
01 1India
01 1Active
01 1Complete
Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
GDUFA
DMF Review : Complete
Rev. Date : 2019-09-11
Pay. Date : 2019-06-10
DMF Number : 32709
Submission : 2018-04-03
Status : Active
Type : II
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Symbiotec Pharmalab Private Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.
They are recognized for Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
One of their notable products is PROGESTERONE USP, with a corresponding US DMF Number 32709.
Remarkably, this DMF maintains an Active status since its submission on April 03, 2018, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of September 11, 2019, and payment made on June 10, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II
