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List of Drug Master Files (JDMF) for Capecitabine Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Dr. Reddy's Laboratories Ltd. (1)

02 Acebright (India) Pharma Private Limited (1)

03 Hetero Labs Limited (1)

04 SciAnda (Changshu) Pharmaceuticals, Ltd. (1)

05 Shandong Anxin Pharmaceutical Co. , Ltd. (1)

06 Shilpa Pharma Lifesciences Limited (1)

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01 Capecitabine (6)

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01 China (2)

02 India (4)

URL Supplier Web Content
231MF10064
No. 77D & 116/117, KIADB Industrial...
2019-03-05
2019-03-05
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228MF10215
7-2-A2,Hetero Corporate,Industrial ...
2016-11-09
2016-11-09
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304MF10148
No. 10678 Wenliang Road, Dongjia To...
2022-11-16
2022-11-16
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229MF10104
No. 16, DongZhou Road Economic Deve...
2017-06-08
2017-06-08
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229MF10131
Shilpa House, #12-6-214/A1, Hyderab...
2017-07-19
2017-07-19
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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 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Capecitabine Drug Master File in Japan (Capecitabine JDMF) empowers Capecitabine API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Capecitabine JDMF during the approval evaluation for pharmaceutical products. At the time of Capecitabine JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

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

Capecitabine Manufacturers | Traders | Suppliers

Capecitabine 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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