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 1Biophore India Pharmaceuticals Pvt Ltd
03 1LGM Pharma
04 1Aptra Synthesis
05 1HRV Global Life Sciences
06 1Aurobindo Pharma Limited
07 1Aurore Life Sciences
08 1CHEMO
09 1Eisai
10 1Enaltec Labs Private Limited
11 1Everest Organics
12 1Fleming Laboratories
13 1Guangzhou Tosun Pharmaceutical
14 1Hangzhou Longshine Bio-Tech
15 1Haoyuan Chemexpress Co.Ltd
16 1Hetero Drugs
17 2MSN Laboratories
18 1SMS Pharmaceuticals
19 1Teva API
20 1Teva Pharmaceutical Industries
21 1Zhejiang Ausun Pharmaceutical
01 4China
02 13India
03 2Israel
04 1Japan
05 1Spain
06 1U.S.A
01 7Active
02 15Blank
01 22Blank
01 1303MF10095
02 1305MF10035
03 20Blank
01 1WC-0021
02 1WC-0021n
03 1WC-0416
04 1WC-0511
05 18Blank
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
GDUFA
DMF Review : Reviewed
Rev. Date : 2018-07-27
Pay. Date : 2018-06-04
DMF Number : 32444
Submission : 2018-06-06
Status : Active
Type : II
Date of Issue : 2024-02-20
Valid Till : 2026-12-06
Written Confirmation Number : WC-0416
Address of the Firm :
NDC Package Code : 58159-050
Start Marketing Date : 2019-11-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : BR |
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-12
Pay. Date : 2020-09-24
DMF Number : 34414
Submission : 2019-12-31
Status : Active
Type : II
Date of Issue : 2021-10-22
Valid Till : 2024-10-21
Written Confirmation Number : WC-0511
Address of the Firm :
NDC Package Code : 73435-003
Start Marketing Date : 2019-12-09
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (10kg/10kg)
Marketing Category : BULK INGREDIENT
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
GDUFA
DMF Review : Reviewed
Rev. Date : 2017-09-15
Pay. Date : 2017-08-09
DMF Number : 31506
Submission : 2017-03-30
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-14
Written Confirmation Number : WC-0021n
Address of the Firm :
NDC Package Code : 14501-0030
Start Marketing Date : 2017-03-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-10-22
Pay. Date : 2019-08-16
DMF Number : 33719
Submission : 2019-08-31
Status : Active
Type : II
Registration Number : 303MF10095
Registrant's Address : No. 5, Donghai 4th Avenue, Zhejiang Chemical Materials Base Linhai Zone, Zhejiang, China
Initial Date of Registration : 2021-06-15
Latest Date of Registration : --
NDC Package Code : 76397-021
Start Marketing Date : 2020-01-01
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2020-11-12
Pay. Date : 2020-09-29
DMF Number : 33601
Submission : 2019-05-14
Status : Active
Type : II
NDC Package Code : 42413-0180
Start Marketing Date : 2019-05-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Date of Issue : 2019-07-15
Valid Till : 2022-07-14
Written Confirmation Number : WC-0021
Address of the Firm :
NDC Package Code : 14501-0030
Start Marketing Date : 2017-03-29
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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