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

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01 Dr. Reddy's Laboratories (1)

02 Aarti Pharmalabs (1)

03 Acebright India Pharma Private Limited (1)

04 Apotex Pharmachem (1)

05 Archimica (1)

06 Cipla (1)

07 Divis Laboratories (1)

08 Hetero Drugs (1)

09 Intas Pharmaceuticals (2)

10 JIANGSU ZW PHARMACEUTICALS CO LTD (1)

11 Jiangsu Hengrui Medicine (1)

12 LIANYUNGANG GUIKE PHARMACEUTICAL CO., LTD. (1)

13 MSN Laboratories (1)

14 Mac-Chem Products (India) Pvt.Ltd (1)

15 Qilu Tianhe Pharmaceutical Co., Ltd. (2)

16 Reliance Life Sciences Private Limited (1)

17 ScinoPharm Taiwan, Ltd (1)

18 Shilpa Medicare (1)

19 Sichuan Xieli Pharmaceutical (1)

20 Signa S.A. de C.V. (1)

21 Sun Pharmaceutical Industries Limited (1)

22 Teva API (1)

23 Viatris (1)

24 Zhejiang Cheng Yi Pharmaceutical Co., Ltd (1)

25 Zhejiang Hisun Pharmaceutical (1)

26 Zydus Lifesciences (1)

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01 CAPECITABINE (9)

02 CAPECITABINE (NON-STERILE API) (2)

03 CAPECITABINE (NON-STERILE, BULK FORM) (1)

04 CAPECITABINE USP (11)

05 CAPECITABINE USP (PROCESS II) (1)

06 CAPECITABINE USP [DRUG SUBSTANCE (NON-STERILE)] (1)

07 CAPECITABINE USP [ROUTE CODE - "CT"] (1)

08 CAPECITABINE USP, NON-STERILE, BULK DRUG SUBSTANCE (1)

09 CAPECITABINE, USP (1)

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01 Canada (1)

02 China (8)

03 India (14)

04 Israel (1)

05 Italy (1)

06 Mexico (1)

07 Taiwan (1)

08 U.S.A (1)

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01 Active (17)

02 Inactive (11)

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01 Complete (10)

02 Blank (18)

URL Supplier Web Content
25054
Active
2011-06-14
Complete
2017-02-06
2016-09-09
II
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URL Supplier Web Content
25266
Active
2011-09-07
N/A
II
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22157
Active
2008-10-27
Complete
2014-04-28
2014-04-21
II
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URL Supplier Web Content
22140
Active
2008-10-27
Complete
2013-12-18
2013-06-21
II
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URL Supplier Web Content
24370
Active
2010-11-09
N/A
II
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URL Supplier Web Content
23808
Active
2010-05-25
Complete
2016-09-14
2016-06-15
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URL Supplier Web Content
24126
Active
2010-08-31
Complete
2014-04-21
2013-09-23
II
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URL Supplier Web Content
24689
Active
2011-03-24
Complete
2014-07-07
2013-02-21
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Looking for 154361-50-9 / Capecitabine API manufacturers, exporters & distributors?

Capecitabine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Capecitabine

Synonyms

154361-50-9, Xeloda, Capiibine, Capecitibine, Captabin, Capecytabine

Cas Number

154361-50-9

Unique Ingredient Identifier (UNII)

6804DJ8Z9U

About Capecitabine

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

Capecitabine Manufacturers

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

Capecitabine Suppliers

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

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

Capecitabine USDMF

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

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

click here to find a list of Capecitabine 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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