Symbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.
KEY PRODUCTS
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01 1Symbiotec Pharmalab
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01 1ESTRADIOL HEMIHYDRATE USP
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01 1India
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01 1Active
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01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2020-04-20
Pay. Date : 2020-03-23
DMF Number : 34147
Submission : 2019-09-11
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 ESTRADIOL HEMIHYDRATE USP, with a corresponding US DMF Number 34147.
Remarkably, this DMF maintains an Active status since its submission on September 11, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of April 20, 2020, and payment made on March 23, 2020, indicating their dedication to facilitating drug approvals, Categorized as Type II