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List of Drug Master Files (DMF) for 15553 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Calyx Chemicals & Pharmaceuticals Limited (1)

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01 PYRAZINAMIDE USP (1)

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01 India (1)

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01 Active (1)

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01 Complete (1)

URL Supplier Web Content
15553
Active
2001-07-31
Complete
2015-10-30
2015-10-15
II
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Looking for Drug Master Files (DMF) for 15553 of Calyx Chemicals And Pharmaceuticals Ltd

Looking for Drug Master Files (DMF) for 15553 of Calyx Chemicals And Pharmaceuticals Ltd 1

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

One of their notable products is PYRAZINAMIDE USP, with a corresponding US DMF Number 15553.

Remarkably, this DMF maintains an Active status since its submission on July 31, 2001, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of October 30, 2015, and payment made on October 15, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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