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01 1IOL Chemicals and Pharmaceuticals

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothIOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

GDUFA

DMF Review : Complete

Rev. Date : 2025-01-24

Pay. Date : 2024-12-02

DMF Number : 36374

Submission : 2021-11-27

Status : Active

Type : II

IOL Chemicals

Looking for Drug Master Files (DMF) for 36374 of Iol Chemicals And Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 36374 of Iol Chemicals And Pharmaceuticals Ltd 1

20

Iol Chemicals And Pharmaceuticals Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

They are recognized for IOL Chemicals is an innovation-driven bulk drug, Intermediate and Specialty Chemicals company.

One of their notable products is LEVETIRACETAM USP, with a corresponding US DMF Number 36374.

Remarkably, this DMF maintains an Active status since its submission on November 27, 2021, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 24, 2025, and payment made on December 02, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II