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01 1Kalintis Healthcare

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GDUFA

DMF Review : Complete

Rev. Date : 2023-01-19

Pay. Date : 2022-11-30

DMF Number : 36730

Submission : 2022-12-10

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 36730 of Kalintis Healthcare Pvt Ltd

Looking for Drug Master Files (DMF) for 36730 of Kalintis Healthcare Pvt Ltd 1

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Kalintis Healthcare Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA.

One of their notable products is OXAZEPAM USP, with a corresponding US DMF Number 36730.

Remarkably, this DMF maintains an Active status since its submission on December 10, 2022, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of January 19, 2023, and payment made on November 30, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II