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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 : 2023-04-04

Pay. Date : 2023-04-17

DMF Number : 36765

Submission : 2022-02-18

Status : Active

Type : II

Nuray Chemicals

Looking for Drug Master Files (DMF) for 36765 of Ss Pharma Llc

Looking for Drug Master Files (DMF) for 36765 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 PRUCALOPRIDE SUCCINATE, with a corresponding US DMF Number 36765.

Remarkably, this DMF maintains an Active status since its submission on February 18, 2022, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of April 04, 2023, and payment made on April 17, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II