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 1ALOSETRON HYDROCHLORIDE
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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 : 2013-10-19
Pay. Date : 2013-09-12
DMF Number : 27378
Submission : 2013-09-16
Status : Active
Type : II
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Nuray Chemicals Pvt Ltd, 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 ALOSETRON HYDROCHLORIDE, with a corresponding US DMF Number 27378.
Remarkably, this DMF maintains an Active status since its submission on September 16, 2013, highlighting commitment to regulatory compliance.
Their GDUFA DMF Review was successfully complete, with a review date of October 19, 2013, and payment made on September 12, 2013, indicating their dedication to facilitating drug approvals, Categorized as Type II