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 1KETOCONAZOLE 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 : 2023-08-23
Pay. Date : 2023-05-26
DMF Number : 38417
Submission : 2023-07-15
Status : Active
Type : II
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Ss 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 KETOCONAZOLE USP, with a corresponding US DMF Number 38417.
Remarkably, this DMF maintains an Active status since its submission on July 15, 2023, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of August 23, 2023, and payment made on May 26, 2023, indicating their dedication to facilitating drug approvals, Categorized as Type II