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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 : 2021-06-16

Pay. Date : 2021-04-30

DMF Number : 35857

Submission : 2021-04-30

Status : Active

Type : II

Nuray Chemicals

Looking for Drug Master Files (DMF) for 35857 of Ss Pharma Llc

Looking for Drug Master Files (DMF) for 35857 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 ACEBUTOLOL HYDROCHLORIDE USP, with a corresponding US DMF Number 35857.

Remarkably, this DMF maintains an Active status since its submission on April 30, 2021, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 16, 2021, and payment made on April 30, 2021, indicating their dedication to facilitating drug approvals, Categorized as Type II