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
02 1BioCryst Pharmaceuticals
03 1CKD Bio Corporation
04 1Guangzhou Tosun Pharmaceutical
05 1Hiray Pharma Solutions
06 1Sms Lifesciences
07 1Tianjin Hankang Pharmaceutical Biotechnology
01 3China
02 2India
03 1South Korea
04 1U.S.A
01 1Active
02 1Inactive
03 5Blank
01 7Blank
01 7Blank
01 1WC-0416
02 6Blank
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-052
Start Marketing Date : 2017-01-03
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Registrant Name : Aging Life Science Co., Ltd.
Registration Date : 2023-01-04
Registration Number : 434-51-ND
Manufacturer Name : Nuray Chemicals Private Limited
Manufacturer Address : Ground Floor, Plot No. 111, SIDCO Industrial Estate, Thiruvallur – 602 003, Tamilnadu, INDIA
| Available Reg Filing : TW |
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35077
Submission : 2020-08-21
Status : Active
Type : II
Registrant Name : Chong Kun Dang Bio Co., Ltd.
Registration Date : 2021-01-28
Registration Number : 2253-6-ND
Manufacturer Name : Chong Kun Dang Bio@PharmaResources (Kaiyuan) Co., Ltd.
Manufacturer Address : 226, Sandan 3-gil, Sapgyo-eup, Yesan-gun, Chungcheongnam-do, 101-ho, 2-1-dong, 3-1-dong, 4-dong @No. 3 Beihuan Road, Kaiyuan, Liaoning Province, 112300, PR, CHINA
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 18961
Submission : 2005-11-17
Status : Inactive
Type : II
A Peramivir manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Peramivir, including repackagers and relabelers. The FDA regulates Peramivir manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Peramivir API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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