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List of Drug Master Files (DMF) for 16678 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Cipla (1)

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01 ALBUTEROL SULFATE 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
16678
Active
2003-06-30
Complete
2015-11-10
2015-09-29
II
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Looking for Drug Master Files (DMF) for 16678 of Cipla Ltd

Looking for Drug Master Files (DMF) for 16678 of Cipla Ltd 1

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Cipla 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 ALBUTEROL SULFATE USP, with a corresponding US DMF Number 16678.

Remarkably, this DMF maintains an Active status since its submission on June 30, 2003, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of November 10, 2015, and payment made on September 29, 2015, indicating their dedication to facilitating drug approvals, Categorized as Type II

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