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List of Certificates of Suitability (CEPs) for Irressat Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN (1)

02 CIPLA LIMITED Mumbai IN (1)

03 Farmhispania, S.A. Montmeló ES (1)

04 HETERO LABS LIMITED Hyderabad IN (1)

05 MAC CHEM PRODUCTS (INDIA) PVT. LTD. Mumbai IN (1)

06 MSN LABORATORIES PRIVATE LIMITED Kardanur Village IN (1)

07 NATCO PHARMA LIMITED Hyderabad IN (1)

08 SHANDONG ANHONG PHARMACEUTICAL CO., LTD. Dezhou City CN (1)

09 SICHUAN XIELI PHARMACEUTICAL CO., LTD. Pengzhou CN (1)

10 SYNTHON BV Nijmegen NL (1)

11 ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. Linhai CN (1)

12 Zhejiang Jiuzhou Pharmaceutical Co., Ltd. Taizhou City CN (1)

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01 Gefitinib (11)

02 Gefitinib, Micronised (1)

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01 China (4)

02 India (6)

03 Netherlands (1)

04 Spain (1)

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01 Valid (11)

02 Withdrawn by Holder (1)

URL Supplier Web Content
R0-CEP 2018-087 - Rev 00
Valid
Chemical
2019-02-05
2866
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R1-CEP 2017-002 - Rev 00
Valid
Chemical
2023-03-24
2866
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R1-CEP 2016-305 - Rev 00
Valid
Chemical
2022-10-06
2866
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R0-CEP 2018-031 - Rev 00
Valid
Chemical
2019-11-19
2866
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URL Supplier Web Content
CEP 2016-227 - Rev 02
Valid
Chemical
2024-01-23
2866
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R1-CEP 2017-028 - Rev 00
Valid
Chemical
2023-03-22
2866
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R0-CEP 2018-281 - Rev 00
Valid
Chemical
2020-02-24
2866
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R1-CEP 2016-154 - Rev 00
Valid
Chemical
2022-06-07
2866
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R1-CEP 2016-241 - Rev 00
Valid
Chemical
2022-11-08
2866
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R0-CEP 2018-236 - Rev 01
Valid
Chemical
2022-02-02
2866
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Looking for 184475-35-2 / Gefitinib API manufacturers, exporters & distributors?

Gefitinib manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Gefitinib

Synonyms

184475-35-2, Iressa, Zd1839, N-(3-chloro-4-fluorophenyl)-7-methoxy-6-(3-morpholinopropoxy)quinazolin-4-amine, Irressat, Zd 1839

Cas Number

184475-35-2

Unique Ingredient Identifier (UNII)

S65743JHBS

About Gefitinib

A selective tyrosine kinase inhibitor for the EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) that is used for the treatment of locally advanced or metastatic NON-SMALL CELL LUNG CANCER.

Irressat Manufacturers

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

Irressat Suppliers

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

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

Irressat CEP

A Irressat CEP of the European Pharmacopoeia monograph is often referred to as a Irressat Certificate of Suitability (COS). The purpose of a Irressat CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Irressat EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Irressat to their clients by showing that a Irressat CEP has been issued for it. The manufacturer submits a Irressat CEP (COS) as part of the market authorization procedure, and it takes on the role of a Irressat CEP holder for the record. Additionally, the data presented in the Irressat CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Irressat DMF.

A Irressat CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Irressat 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 Irressat suppliers with CEP (COS) on PharmaCompass.

Irressat Manufacturers | Traders | Suppliers

Irressat 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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