KEY PRODUCTS
Neuland Laboratories- A dedicated 100% API provider.
01 1Neuland Laboratories
01 1LINEZOLID USP (PROCESS-II)
01 1India
01 1Active
01 1Complete
Neuland Laboratories- A dedicated 100% API provider.
GDUFA
DMF Review : Complete
Rev. Date : 2024-02-21
Pay. Date : 2024-01-23
DMF Number : 36946
Submission : 2022-03-31
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 LINEZOLID USP (PROCESS-II), with a corresponding US DMF Number 36946.
Remarkably, this DMF maintains an Active status since its submission on March 31, 2022, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of February 21, 2024, and payment made on January 23, 2024, indicating their dedication to facilitating drug approvals, Categorized as Type II
