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 1TAPI Technology & API Services
10 1Aurobindo Pharma Limited
11 1Aurore Life Sciences
12 2Cipla
13 1Fujian South Pharmaceutical
14 1Glenmark Life Sciences
15 1Glenmark Pharmaceuticals
16 1MSN Laboratories
17 1Morepen Laboratories
18 1Natco Pharma
19 1Raghava Life Sciences
20 1Saptagir Laboratories
21 1Sun Pharmaceutical Industries Limited
22 1Symed Labs
23 1Teva Pharmaceutical Industries
01 1China
02 1Czech Republic
03 1France
04 19India
05 2Israel
06 1Spain
01 13Active
02 12Blank
01 25Blank
01 25Blank
01 1WC-0416
02 24Blank
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
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