KEY PRODUCTS
Neuland Laboratories- A dedicated 100% API provider.
01 1Neuland Laboratories
01 1EZETIMIBE USP (FORM-X)
01 1India
01 1Active
01 1Complete
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2018-08-14
Pay. Date : 2018-07-05
DMF Number : 25543
Submission : 2011-11-30
Status : Active
Type : II
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Neuland Laboratories Ltd, based in India, is a pharmaceutical company that stands out with its certifications from FDA and EDQM.
They are recognized for Neuland Laboratories- A dedicated 100% API provider.
One of their notable products is EZETIMIBE USP (FORM-X), with a corresponding US DMF Number 25543.
Remarkably, this DMF maintains an Active status since its submission on November 30, 2011, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 14, 2018, and payment made on July 05, 2018, indicating their dedication to facilitating drug approvals, Categorized as Type II
