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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 : 2013-10-19

Pay. Date : 2013-09-12

DMF Number : 27378

Submission : 2013-09-16

Status : Active

Type : II

Nuray Chemicals

Looking for Drug Master Files (DMF) for 27378 of Nuray Chemicals Pvt Ltd

Looking for Drug Master Files (DMF) for 27378 of Nuray Chemicals Pvt Ltd 1

20

Nuray Chemicals Pvt Ltd, 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 ALOSETRON HYDROCHLORIDE, with a corresponding US DMF Number 27378.

Remarkably, this DMF maintains an Active status since its submission on September 16, 2013, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 19, 2013, and payment made on September 12, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II