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List of Drug Master Files (DMF) for 23353 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 CTX Lifesciences (1)

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01 OXCARBAZEPINE (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
23353
Active
2009-11-30
Complete
2014-06-17
2013-02-20
II
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Looking for Drug Master Files (DMF) for 23353 of Ctx Life Sciences Pvt Ltd

Looking for Drug Master Files (DMF) for 23353 of Ctx Life Sciences Pvt Ltd 1

20

Ctx Life Sciences Pvt Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA, EDQM and WHO-GMP.

One of their notable products is OXCARBAZEPINE, with a corresponding US DMF Number 23353.

Remarkably, this DMF maintains an Active status since its submission on November 30, 2009, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 17, 2014, and payment made on February 20, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II

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