Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 2Nuray Chemicals Private Limited
03 1FARMAK, a.s
04 1Biophore India Pharmaceuticals Pvt Ltd
05 1Inabata France S.A.S
06 1Virupaksha Organics
07 1HRV Global Life Sciences
08 1Neuland Laboratories
09 1Aurobindo Pharma Limited
10 1Aurore Life Sciences
11 2Cipla
12 1Fujian South Pharmaceutical
13 1Glenmark Life Sciences
14 1Glenmark Pharmaceuticals
15 1MSN Laboratories
16 1Morepen Laboratories
17 1Natco Pharma
18 1Saptagir Laboratories
19 1Sun Pharmaceutical Industries Limited
20 1Symed Labs
21 1TAPI Technology & API Services
22 1Teva Pharmaceutical Industries
01 1China
02 1Czech Republic
03 1France
04 18India
05 2Israel
06 1Spain
01 13Active
02 11Blank
01 24Blank
01 24Blank
01 1WC-0416
02 23Blank
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 : 2020-11-01
Pay. Date : 2020-09-15
DMF Number : 35067
Submission : 2020-09-18
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 : 58159-079
Start Marketing Date : 2020-06-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : Reviewed
Rev. Date : 2023-03-31
Pay. Date : 2023-03-21
DMF Number : 37694
Submission : 2022-11-30
Status : Active
Type : II
NDC Package Code : 73435-031
Start Marketing Date : 2022-12-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
IKF/Pharmasynthese have been with fine chemicals market and APIs performance for more than 40 years.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38240
Submission : 2023-03-31
Status : Active
Type : II
NDC Package Code : 58032-1031
Start Marketing Date : 2023-03-30
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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 : 2023-03-28
Pay. Date : 2023-02-08
DMF Number : 36953
Submission : 2023-02-08
Status : Active
Type : II
NDC Package Code : 58159-079
Start Marketing Date : 2020-06-17
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37523
Submission : 2023-03-27
Status : Active
Type : II
NDC Package Code : 66039-960
Start Marketing Date : 2022-02-10
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
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