Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
KEY PRODUCTS
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01 1Nuray Chemicals Private Limited
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01 1METHYLTESTOSTERONE USP
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01 1India
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01 1Active
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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 : 2020-01-24
Pay. Date : 2019-12-03
DMF Number : 34373
Submission : 2019-12-17
Status : Active
Type : II
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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 METHYLTESTOSTERONE USP, with a corresponding US DMF Number 34373.
Remarkably, this DMF maintains an Active status since its submission on December 17, 2019, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of January 24, 2020, and payment made on December 03, 2019, indicating their dedication to facilitating drug approvals, Categorized as Type II