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01 1FERMION OY Espoo FI
02 1CIPLA LIMITED Mumbai IN
03 1FRESENIUS KABI ONCOLOGY LIMITED Kalyani IN
04 1HETERO LABS LIMITED Hyderabad IN
05 1HUBEI HAOSUN PHARMACEUTICAL CO., LTD. Ezhou CN
06 1LAURUS LABS LIMITED Hyderabad IN
07 1MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN
08 1QILU PHARMACEUTICAL CO., LTD. Jinan CN
09 1SCINOPHARM TAIWAN, LTD. Shan-Hua TW
10 2SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN
11 1SICHUAN XIELI PHARMACEUTICAL CO., LTD. Pengzhou CN
01 10Irinotecan hydrochloride trihydrate
02 1Irinotecan hydrochloride trihydrate, Form-B
03 1Irinotecan hydrochloride trihydrate, Process 2
01 3China
02 1Finland
03 7India
04 1Taiwan
01 11Valid
02 1Withdrawn by Holder
Irinotecan Hydrochloride Trihydrate
Certificate Number : CEP 2017-236 - Rev 02
Status : Valid
Issue Date : 2023-09-22
Type : Chemical
Substance Number : 2675
Irinotecan Hydrochloride Trihydrate
Certificate Number : CEP 2017-234 - Rev 03
Status : Valid
Issue Date : 2024-04-22
Type : Chemical
Substance Number : 2675
Irinotecan Hydrochloride Trihydrate
Certificate Number : R0-CEP 2020-025 - Rev 00
Status : Valid
Issue Date : 2022-05-10
Type : Chemical
Substance Number : 2675
Irinotecan Hydrochloride Trihydrate
Certificate Number : CEP 2019-292 - Rev 02
Status : Valid
Issue Date : 2023-12-11
Type : Chemical
Substance Number : 2675
Irinotecan Hydrochloride Trihydrate
Certificate Number : CEP 2018-063 - Rev 02
Status : Valid
Issue Date : 2024-11-15
Type : Chemical
Substance Number : 2675
Irinotecan Hydrochloride Trihydrate
Certificate Number : CEP 2016-276 - Rev 01
Status : Valid
Issue Date : 2024-06-26
Type : Chemical
Substance Number : 2675
Irinotecan Hydrochloride Trihydrate
Certificate Number : CEP 2017-163 - Rev 01
Status : Valid
Issue Date : 2024-09-11
Type : Chemical
Substance Number : 2675
Irinotecan Hydrochloride Trihydrate, Process 2
Certificate Number : R0-CEP 2019-156 - Rev 01
Status : Valid
Issue Date : 2022-07-21
Type : Chemical
Substance Number : 2675
Irinotecan Hydrochloride Trihydrate
Certificate Number : R1-CEP 2017-147 - Rev 00
Status : Valid
Issue Date : 2023-07-04
Type : Chemical
Substance Number : 2675
Irinotecan Hydrochloride Trihydrate
Certificate Number : R1-CEP 2017-096 - Rev 00
Status : Valid
Issue Date : 2023-04-24
Type : Chemical
Substance Number : 2675
A Irinotecan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Irinotecan, including repackagers and relabelers. The FDA regulates Irinotecan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Irinotecan 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 Irinotecan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Irinotecan supplier is an individual or a company that provides Irinotecan active pharmaceutical ingredient (API) or Irinotecan finished formulations upon request. The Irinotecan suppliers may include Irinotecan API manufacturers, exporters, distributors and traders.
click here to find a list of Irinotecan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Irinotecan CEP of the European Pharmacopoeia monograph is often referred to as a Irinotecan Certificate of Suitability (COS). The purpose of a Irinotecan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Irinotecan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Irinotecan to their clients by showing that a Irinotecan CEP has been issued for it. The manufacturer submits a Irinotecan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Irinotecan CEP holder for the record. Additionally, the data presented in the Irinotecan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Irinotecan DMF.
A Irinotecan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Irinotecan 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 Irinotecan suppliers with CEP (COS) on PharmaCompass.
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