Inke S.A: APIs manufacturing plant.
01 1Inke S.A
02 1Nuray Chemicals Private Limited
03 1FARMAK, a.s
04 1Biophore India Pharmaceuticals Pvt Ltd
05 1Metrochem API Private Limited
06 1Dr. Reddy's Laboratories
07 1Virupaksha Organics
08 1Aptra Synthesis
09 1HRV Global Life Sciences
10 1Neuland Laboratories
11 1Aurobindo Pharma Limited
12 1Aurore Life Sciences
13 1Glenmark Life Sciences
14 1HONOUR LAB LTD
15 1Hetero Drugs
16 2MSN Laboratories
17 1Morepen Laboratories
18 1Natco Pharma
19 1Navinta
20 1Optimus Pharma
21 1Saptagir Laboratories
22 1Synaptics Labs
23 1Teva API
24 1Zenfold Sustainable Technologies
01 1Czech Republic
02 21India
03 1Israel
04 1Spain
05 1U.S.A
01 13Active
02 12Blank
01 25Blank
01 25Blank
01 1WC-0021A4
02 1WC-0021n
03 1WC-0037
04 1WC-0416
05 21Blank
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 : 2020-09-15
Pay. Date : 2020-08-03
DMF Number : 35066
Submission : 2020-08-05
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 : 58159-078
Start Marketing Date : 2020-06-16
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.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 38912
Submission : 2023-09-26
Status : Active
Type : II
Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37205
Submission : 2022-06-24
Status : Active
Type : II
NDC Package Code : 73435-024
Start Marketing Date : 2022-12-21
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (25kg/25kg)
Marketing Category : BULK INGREDIENT
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 37979
Submission : 2023-02-21
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36341
Submission : 2021-11-03
Status : Active
Type : II
Date of Issue : 2022-06-08
Valid Till : 2025-06-16
Written Confirmation Number : WC-0037
Address of the Firm :
NDC Package Code : 58032-2037
Start Marketing Date : 2022-03-31
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
Available Reg Filing : ASMF |
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