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01 1Phytex Australia

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothExperts in producing high-quality APIs from natural sources, specializing in advanced extraction and isolation techniques.

GDUFA

DMF Review : Complete

Rev. Date : 2022-02-17

Pay. Date : 2021-09-16

DMF Number : 7410

Submission : 1988-03-30

Status : Active

Type : II

Phytex Company Banner

Looking for Drug Master Files (DMF) for 7410 of Phytex Australia Pvt Ltd

Looking for Drug Master Files (DMF) for 7410 of Phytex Australia Pvt Ltd 1

20

Phytex Australia Pvt Ltd, based in Australia, is a pharmaceutical company that stands out with its certifications from FDA.

They are recognized for Experts in producing high-quality APIs from natural sources, specializing in advanced extraction and isolation techniques.

One of their notable products is METHSCOPOLAMINE BROMIDE, with a corresponding US DMF Number 7410.

Remarkably, this DMF maintains an Active status since its submission on March 30, 1988, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 17, 2022, and payment made on September 16, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II