Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
01 1Biophore India Pharmaceuticals Pvt Ltd
02 1LGM Pharma
03 1Metrochem API Private Limited
04 1Nuray Chemicals Private Limited
05 1Omgene Life Sciences Pvt. Ltd
06 2Alembic Pharmaceuticals Limited
07 1Apicore LLC
08 1Apotex Pharmachem
09 1CHEMO
10 1Deva Holding AS
11 1HONOUR LAB LTD
12 1Haoyuan Chemexpress Co.Ltd
13 1Hetero Drugs
14 1MSN Laboratories
15 3Maithri Drugs
16 1Shilpa Medicare
17 1Sionc Pharmaceuticals
18 1Symed Labs
19 1Viatris
20 1Zhejiang Ausun Pharmaceutical
21 1Zhejiang Huayi Pharmaceutical Co., Ltd.
01 1Canada
02 3China
03 16India
04 1Spain
05 1Turkey
06 2U.S.A
01 10Active
02 14Blank
01 24Blank
01 24Blank
01 1WC-0082
02 1WC-0082A11
03 1WC-0273A3
04 1WC-0407
05 20Blank
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 : 33947
Submission : 2019-06-18
Status : Active
Type : II
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.
Nuray is an expert in the synthesis of Niche novel APIs, the first to launch Generics, NCEs, Advanced Intermediates // USFDA certified.
NDC Package Code : 58159-113
Start Marketing Date : 2024-11-02
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (35kg/35kg)
Marketing Category : BULK INGREDIENT
Omgene: R&D-based biopharmaceutical company with GMP facilities, focused on innovation and high-quality, affordable medicines.
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-03-01
Pay. Date : 2019-01-28
DMF Number : 33061
Submission : 2018-12-31
Status : Active
Type : II
NDC Package Code : 69037-0036
Start Marketing Date : 2015-12-21
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39287
Submission : 2023-12-18
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 35163
Submission : 2020-09-09
Status : Active
Type : II
NDC Package Code : 42973-307
Start Marketing Date : 2020-12-06
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-04-23
Pay. Date : 2019-03-20
DMF Number : 32123
Submission : 2017-10-13
Status : Active
Type : II
Date of Issue : 2020-09-09
Valid Till : 2023-06-28
Written Confirmation Number : WC-0407
Address of the Firm :
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 33561
Submission : 2019-03-07
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 36155
Submission : 2021-07-31
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 39699
Submission : 2024-03-29
Status : Active
Type : II
NDC Package Code : 14501-0116
Start Marketing Date : 2024-03-28
End Marketing Date : 2025-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-09-12
Pay. Date : 2019-07-16
DMF Number : 33974
Submission : 2019-07-30
Status : Active
Type : II
Date of Issue : 2022-06-17
Valid Till : 2025-07-02
Written Confirmation Number : WC-0082
Address of the Firm :
GDUFA
DMF Review : Reviewed
Rev. Date : 2019-06-06
Pay. Date : 2019-05-23
DMF Number : 33828
Submission : 2019-05-31
Status : Active
Type : II
Date of Issue : 2021-10-05
Valid Till : 2022-07-02
Written Confirmation Number : WC-0082A11
Address of the Firm :
Date of Issue : 2021-03-25
Valid Till : 2023-05-11
Written Confirmation Number : WC-0273A3
Address of the Firm :
A Selexipag manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Selexipag, including repackagers and relabelers. The FDA regulates Selexipag manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Selexipag 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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A Selexipag supplier is an individual or a company that provides Selexipag active pharmaceutical ingredient (API) or Selexipag finished formulations upon request. The Selexipag suppliers may include Selexipag API manufacturers, exporters, distributors and traders.
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