KEY PRODUCTS
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
01 1Nuray Chemicals Private Limited
01 1OXANDROLONE USP
01 1India
01 1Active
01 1Complete
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Complete
Rev. Date : 2017-12-05
Pay. Date : 2017-07-28
DMF Number : 31920
Submission : 2017-10-28
Status : Active
Type : II
20
Novitium Pharma Llc, based in India, is a pharmaceutical company that stands out with its certifications from FDA and WHO-GMP.
They are recognized for Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
One of their notable products is OXANDROLONE USP, with a corresponding US DMF Number 31920.
Remarkably, this DMF maintains an Active status since its submission on October 28, 2017, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of December 05, 2017, and payment made on July 28, 2017, indicating their dedication to facilitating drug approvals, Categorized as Type II
