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01 1Symbiotec Pharmalab

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSymbiotec: Global API manufacturer, specializing in Cortico-Steroids & Steroid-Hormone APIs.

GDUFA

DMF Review : Complete

Rev. Date : 2023-11-02

Pay. Date : 2023-10-03

DMF Number : 25534

Submission : 2011-11-28

Status : Active

Type : II

Symbiotec Pharmalab

Looking for Drug Master Files (DMF) for 25534 of Symbiotec Pharmalab Private Ltd

Looking for Drug Master Files (DMF) for 25534 of Symbiotec Pharmalab Private Ltd 1

20

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 TESTOSTERONE UNDECANOATE, with a corresponding US DMF Number 25534.

Remarkably, this DMF maintains an Active status since its submission on November 28, 2011, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 02, 2023, and payment made on October 03, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II