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01 1Kalintis Healthcare

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GDUFA

DMF Review : Complete

Rev. Date : 2022-02-18

Pay. Date : 2022-01-13

DMF Number : 36664

Submission : 2022-01-20

Status : Active

Type : II

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Looking for Drug Master Files (DMF) for 36664 of Kalintis Healthcare Private Ltd

Looking for Drug Master Files (DMF) for 36664 of Kalintis Healthcare Private Ltd 1

20

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

One of their notable products is TORSEMIDE USP, with a corresponding US DMF Number 36664.

Remarkably, this DMF maintains an Active status since its submission on January 20, 2022, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of February 18, 2022, and payment made on January 13, 2022, indicating their dedication to facilitating drug approvals, Categorized as Type II