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 1METHYLPREDNISOLONE, USP (MICRONIZED)
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01 1India
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01 1Active
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01 1Complete
GDUFA
DMF Review : Complete
Rev. Date : 2014-07-21
Pay. Date : 2013-12-17
DMF Number : 27783
Submission : 2013-11-25
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 METHYLPREDNISOLONE, USP (MICRONIZED), with a corresponding US DMF Number 27783.
Remarkably, this DMF maintains an Active status since its submission on November 25, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of July 21, 2014, and payment made on December 17, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II