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List of Drug Master Files (DMF) for 32014 Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Enaltec Labs Private Limited (1)

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01 CHLORPROMAZINE HYDROCHLORIDE 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
32014
Active
2018-05-25
Complete
2018-06-22
2018-05-15
II
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Looking for Drug Master Files (DMF) for 32014 of Enaltec Labs Private Ltd

Looking for Drug Master Files (DMF) for 32014 of Enaltec Labs Private Ltd 1

20

Enaltec Labs Private 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 CHLORPROMAZINE HYDROCHLORIDE USP, with a corresponding US DMF Number 32014.

Remarkably, this DMF maintains an Active status since its submission on May 25, 2018, highlighting commitment to regulatory compliance.

Their GDUFA DMF Review was successfully complete, with a review date of June 22, 2018, and payment made on May 15, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II

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