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List of Drug Master Files (DMF) of Selexipag Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Biophore India Pharmaceuticals Pvt Ltd (1)

02 Alembic Pharmaceuticals Limited (1)

03 Apicore LLC (1)

04 Apotex Pharmachem (1)

05 HONOUR LAB LTD (1)

06 Maithri Drugs (3)

07 Zhejiang Huayi Pharmaceutical Co., Ltd. (1)

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01 SELEXIPAG (4)

02 SELEXIPAG (AMORPHOUS) (1)

03 SELEXIPAG (FORM-I) (1)

04 SELEXIPAG (FORM-III) (1)

05 SELEXIPAG (FORM-P) (1)

06 SELEXIPAG-MANNITOL PREMIX (1)

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01 Canada (1)

02 China (1)

03 India (7)

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01 Active (9)

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01 Complete (4)

02 Blank (5)

URL Supplier Web Content
33974
Active
2019-07-30
Complete
2019-09-12
2019-07-16
II
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URL Supplier Web Content
35163
Active
2020-09-09
N/A
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URL Supplier Web Content
33828
Active
2019-05-31
Complete
2019-06-06
2019-05-23
II
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URL Supplier Web Content
33061
Active
2018-12-31
Complete
2019-03-01
2019-01-28
II
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URL Supplier Web Content
33561
Active
2019-03-07
N/A
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URL Supplier Web Content
32123
Active
2017-10-13
Complete
2019-04-23
2019-03-20
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URL Supplier Web Content
36155
Active
2021-07-31
N/A
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URL Supplier Web Content
39287
Active
2023-12-18
N/A
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Looking for 475086-01-2 / Selexipag API manufacturers, exporters & distributors?

Selexipag manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Selexipag API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Selexipag manufacturer or Selexipag supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Selexipag manufacturer or Selexipag supplier.

PharmaCompass also assists you with knowing the Selexipag API Price utilized in the formulation of products. Selexipag API Price is not always fixed or binding as the Selexipag Price is obtained through a variety of data sources. The Selexipag Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Selexipag

Synonyms

475086-01-2, Ns-304, Uptravi, Act-293987, Ns 304, Act 293987

Cas Number

475086-01-2

Unique Ingredient Identifier (UNII)

5EXC0E384L

About Selexipag

Selexipag was approved by the United States FDA on December 22, 2015 for the treatment of pulmonary arterial hypertension (PAH) to delay disease progression and reduce risk of hospitalization. PAH is a relatively rare disease with usually a poor prognosis requiring more treatment options to prolong long-term outcomes. Marketed by Actelion Pharmaceuticals under brand name Uptravi, selexipag and its active metabolite, ACT-333679 (MRE-269), act as agonists of the prostacyclin receptor to increase vasodilation in the pulmonary circulation and decrease elevated pressure in the blood vessels supplying blood to the lungs.

Selexipag Manufacturers

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.

click here to find a list of Selexipag manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Selexipag Suppliers

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.

click here to find a list of Selexipag suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Selexipag USDMF

A Selexipag DMF (Drug Master File) is a document detailing the whole manufacturing process of Selexipag active pharmaceutical ingredient (API) in detail. Different forms of Selexipag DMFs exist exist since differing nations have different regulations, such as Selexipag USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Selexipag DMF submitted to regulatory agencies in the US is known as a USDMF. Selexipag USDMF includes data on Selexipag's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Selexipag USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Selexipag suppliers with USDMF on PharmaCompass.

Selexipag Manufacturers | Traders | Suppliers

Selexipag Manufacturers, Traders, Suppliers 1
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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