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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 : 2023-11-15

Pay. Date : 2023-09-27

DMF Number : 38890

Submission : 2023-09-29

Status : Active

Type : II

Nuray Chemicals

Looking for Drug Master Files (DMF) for 38890 of Ss Pharma Llc

Looking for Drug Master Files (DMF) for 38890 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 SODIUM PHENYLBUTYRATE USP, with a corresponding US DMF Number 38890.

Remarkably, this DMF maintains an Active status since its submission on September 29, 2023, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 15, 2023, and payment made on September 27, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II