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01 1Symbiotica Speciality Ingredients Sdn Bhd

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothSymbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.

GDUFA

DMF Review : Complete

Rev. Date : 2017-11-07

Pay. Date : 2017-06-05

DMF Number : 31423

Submission : 2017-02-01

Status : Active

Type : II

Company Banner

Looking for Drug Master Files (DMF) for 31423 of Symbiotica Speciality Ingredients Sdn Bhd

Looking for Drug Master Files (DMF) for 31423 of Symbiotica Speciality Ingredients Sdn Bhd 1

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Symbiotica Speciality Ingredients Sdn Bhd, based in Malaysia, is a pharmaceutical company that stands out with its certifications from FDA.

They are recognized for Symbiotica delivers high-quality APIs through advanced R&D, GMP-certified manufacturing, & trusted global pharmaceutical partnerships.

One of their notable products is HYDROCORTISONE VALERATE USP, with a corresponding US DMF Number 31423.

Remarkably, this DMF maintains an Active status since its submission on February 01, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 07, 2017, and payment made on June 05, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II