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List of Drug Master Files (KDMF) for Capecitabine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Divi`s Laboratories Limited (1)

02 Hetero Labs Limited (Unit-1) (1)

03 Lianyungang Guike Pharmaceutical Co., Ltd. (1)

04 Patheon API Inc. (1)

05 Shilpa Pharma Lifesciences Limited (1)

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01 Aging Life Science Co., Ltd. (1)

02 Boryeong Co., Ltd. (1)

03 Leesung International Co., Ltd. (1)

04 Masung LS Co., Ltd. (1)

05 Pharmaline Co., Ltd. (1)

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01 Capecitabine (5)

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01 China (1)

02 India (3)

03 U.S.A (1)

URL Supplier Web Content
Pharmaline Co., Ltd.
2021-05-04
20210504-209-J-970
Divi`s Laboratories Limit...
India
Unit-2,Chippada (V) Annav...
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Leesung International Co., Ltd.
2021-03-10
20210310-209-J-685
Hetero Labs Limited (Unit...
India
Sy.No.10, IDA,Gaddapothar...
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Aging Life Science Co., Ltd.
2023-12-11
20231211-209-J-1579
Lianyungang Guike Pharmac...
China
1, Xianfeng Road, Dapu In...
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Boryeong Co., Ltd.
2022-04-25
20220425-209-J-1277
Patheon API Inc.
U.S.A
6173 East Old Marion High...
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Masung LS Co., Ltd.
2021-04-20
20210420-209-J-850
Shilpa Pharma Lifescience...
India
Plot Nos. 33, 33a, 40-47,...
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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 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Capecitabine Drug Master File in Korea (Capecitabine KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Capecitabine. The MFDS reviews the Capecitabine KDMF as part of the drug registration process and uses the information provided in the Capecitabine KDMF to evaluate the safety and efficacy of the drug.

After submitting a Capecitabine KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Capecitabine API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Capecitabine suppliers with KDMF on PharmaCompass.

Capecitabine Manufacturers | Traders | Suppliers

Capecitabine Manufacturers, Traders, Suppliers 1
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We have 5 companies offering Capecitabine

Get in contact with the supplier of your choice:

  1. Divis Laboratories
  2. Hetero Drugs
  3. LIANYUNGANG GUIKE PHARMACEUTICAL CO., LTD.
  4. Patheon
  5. Shilpa Medicare
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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