DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
01 2DR. REDDY'S LABORATORIES LIMITED Hyderabad IN
02 1GRANULES INDIA LIMITED Hyderabad IN
03 1CDYMAX (INDIA) PHARMA PRIVATE LIMITED Bangalore IN
04 1CIPLA LIMITED Mumbai IN
05 1DIVI'S LABORATORIES LIMITED Hyderabad IN
06 1EXCELLA GMBH & CO. KG Feucht DE
07 1HETERO LABS LIMITED Hyderabad IN
08 2INTAS PHARMACEUTICALS LIMITED Ahmedabad IN
09 1MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN
10 1MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN
11 1MYLAN LABORATORIES LIMITED Hyderabad IN
12 1SCINOPHARM TAIWAN, LTD. Shan-Hua TW
13 1SHANDONG ANXIN PHARMACEUTICAL CO., LTD Dongjia Town CN
14 1SHANDONG BOYUAN PHARMACEUTICAL CO., LTD. Jinan City CN
15 1SHANDONG LIXIN PHARMACEUTICAL CO. LTD. Zibo CN
16 1SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN
17 1SUN PHARMACEUTICAL INDUSTRIES LIMITED Mumbai IN
18 1TEVA PHARMACEUTICAL INDUSTRIES LTD Tel Aviv - Jaffa IL
19 1Zhejiang Hisun Pharmaceutical Co., Ltd. Taizhou City CN
01 20Capecitabine
02 1Capecitabine, Process II
01 4China
02 1Germany
03 13India
04 1Israel
05 1Taiwan
06 1U.S.A
01 1Expired
02 16Valid
03 4Withdrawn by Holder
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Certificate Number : R1-CEP 2014-109 - Rev 02
Status : Valid
Issue Date : 2022-09-13
Type : Chemical
Substance Number : 2762
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.
Certificate Number : CEP 2019-091 - Rev 01
Status : Valid
Issue Date : 2024-06-06
Type : Chemical
Substance Number : 2762
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
DRL offers a portfolio of products & services, including APIs, CMO services, generics, biosimilars & differentiated formulations.
Certificate Number : R1-CEP 2014-203 - Rev 00
Status : Valid
Issue Date : 2020-05-07
Type : Chemical
Substance Number : 2762
Certificate Number : R1-CEP 2014-355 - Rev 02
Status : Valid
Issue Date : 2023-06-16
Type : Chemical
Substance Number : 2762
Certificate Number : R1-CEP 2015-325 - Rev 01
Status : Valid
Issue Date : 2022-06-24
Type : Chemical
Substance Number : 2762
Certificate Number : CEP 2018-015 - Rev 01
Status : Valid
Issue Date : 2024-03-20
Type : Chemical
Substance Number : 2762
Certificate Number : CEP 2014-189 - Rev 04
Status : Valid
Issue Date : 2024-11-27
Type : Chemical
Substance Number : 2762
Certificate Number : R1-CEP 2014-332 - Rev 02
Status : Valid
Issue Date : 2023-02-07
Type : Chemical
Substance Number : 2762
Certificate Number : R1-CEP 2016-140 - Rev 00
Status : Valid
Issue Date : 2022-09-08
Type : Chemical
Substance Number : 2762
Certificate Number : R0-CEP 2021-316 - Rev 00
Status : Valid
Issue Date : 2022-10-19
Type : Chemical
Substance Number : 2762
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.
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.
A Capecitabine CEP of the European Pharmacopoeia monograph is often referred to as a Capecitabine Certificate of Suitability (COS). The purpose of a Capecitabine CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Capecitabine EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Capecitabine to their clients by showing that a Capecitabine CEP has been issued for it. The manufacturer submits a Capecitabine CEP (COS) as part of the market authorization procedure, and it takes on the role of a Capecitabine CEP holder for the record. Additionally, the data presented in the Capecitabine CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Capecitabine DMF.
A Capecitabine CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Capecitabine CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Capecitabine suppliers with CEP (COS) on PharmaCompass.
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