KEY PRODUCTS
Neuland Laboratories- A dedicated 100% API provider.
01 1Neuland Laboratories
01 1MIRTAZAPINE USP (ACETONE ROUTE)
01 1India
01 1Active
01 1Complete
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2023-12-28
Pay. Date : 2023-11-24
DMF Number : 30850
Submission : 2016-09-07
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 MIRTAZAPINE USP (ACETONE ROUTE), with a corresponding US DMF Number 30850.
Remarkably, this DMF maintains an Active status since its submission on September 07, 2016, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 28, 2023, and payment made on November 24, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II
