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01 1Nuray Chemicals Private Limited

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

GDUFA

DMF Review : Complete

Rev. Date : 2017-03-17

Pay. Date : 2017-02-13

DMF Number : 31385

Submission : 2017-02-28

Status : Active

Type : II

Nuray Chemicals

Looking for Drug Master Files (DMF) for 31385 of Ss Pharma Llc

Looking for Drug Master Files (DMF) for 31385 of Ss Pharma Llc 1

20

Ss Pharma Llc, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.

They are recognized for Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.

One of their notable products is TREPROSTINIL DIOLAMINE, with a corresponding US DMF Number 31385.

Remarkably, this DMF maintains an Active status since its submission on February 28, 2017, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of March 17, 2017, and payment made on February 13, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II