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

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01 Minakem (formerly Delmar Chemicals) (1)

02 Alembic Pharmaceuticals Limited (2)

03 Aurobindo Pharma Limited (1)

04 Chongqing Carelife Pharmaceutical Co., Ltd. (1)

05 Cipla (3)

06 Granules India Limited (1)

07 Hetero Drugs (1)

08 MSN Laboratories (2)

09 Natco Pharma (2)

10 Reliance Life Sciences Private Limited (1)

11 Sichuan Xieli Pharmaceutical (1)

12 Teva API (1)

13 Yabao Pharmaceutical Group Co. Ltd (1)

14 Zhejiang Jiuzhou Pharmaceutical (1)

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01 SORAFENIB HEMITOSYLATE (1)

02 SORAFENIB TOSYLATE (8)

03 SORAFENIB TOSYLATE (FORM 1) (1)

04 SORAFENIB TOSYLATE (FORM-I) (1)

05 SORAFENIB TOSYLATE (FORM-III) [ROUTE CODE "SR"] (1)

06 SORAFENIB TOSYLATE (VERSION NO.: 1) (1)

07 SORAFENIB TOSYLATE 3 (1)

08 SORAFENIB TOSYLATE USP (4)

09 SORAFENIB TOSYLATE USP (FORM-I) (1)

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01 Canada (1)

02 China (4)

03 India (13)

04 Israel (1)

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01 Active (16)

02 Inactive (3)

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01 Complete (10)

02 Blank (9)

32140
Active
2017-12-20
Complete
2018-07-27
2018-01-19
II
Minakem Delmar

Swiss Biotech Day

Not Confirmed

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URL Supplier Web Content
29941
Active
2015-11-29
Complete
2016-01-26
2015-11-19
II
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URL Supplier Web Content
32840
Active
2018-07-09
Complete
2018-08-22
2018-07-23
II
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URL Supplier Web Content
32642
Active
2018-03-30
N/A
II
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URL Supplier Web Content
30235
Active
2016-01-28
Complete
2016-09-19
2016-08-18
II
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URL Supplier Web Content
30180
Active
2016-01-30
Complete
2016-12-22
2016-09-30
II
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26693
Active
2012-12-21
Complete
2014-09-09
2014-02-25
II
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URL Supplier Web Content
28556
Active
2014-09-23
N/A
II
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URL Supplier Web Content
30234
Active
2016-02-23
Complete
2016-04-01
2016-02-01
II
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29340
Active
2015-06-30
Complete
2015-09-18
2015-06-12
II
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Looking for 475207-59-1 / Sorafenib API manufacturers, exporters & distributors?

Sorafenib manufacturers, exporters & distributors 1

22

PharmaCompass offers a list of Sorafenib 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 Sorafenib manufacturer or Sorafenib supplier for your needs.

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

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

API | Excipient name

Sorafenib

Synonyms

475207-59-1, Nexavar, Sorafenib tosylate [usan], Sorafenib (tosylate), Sorafenib tosilate, Bay 54-9085

Cas Number

475207-59-1

Unique Ingredient Identifier (UNII)

5T62Q3B36J

About Sorafenib

A niacinamide and phenylurea derivative that inhibits multiple intracellular and cell surface kinases thought to be involved in ANGIOGENESIS, including RAF KINASES and VEGF RECEPTORS. It is used in the treatment of advanced RENAL CELL CARCINOMA and HEPATOCELLULAR CARCINOMA, and for treatment of THYROID CARCINOMA refractory to radioactive iodine therapy.

Sorafenib Manufacturers

A Sorafenib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Sorafenib, including repackagers and relabelers. The FDA regulates Sorafenib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Sorafenib 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 Sorafenib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Sorafenib Suppliers

A Sorafenib supplier is an individual or a company that provides Sorafenib active pharmaceutical ingredient (API) or Sorafenib finished formulations upon request. The Sorafenib suppliers may include Sorafenib API manufacturers, exporters, distributors and traders.

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

Sorafenib USDMF

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

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

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

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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