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

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01 Mac-Chem Products (India) Pvt.Ltd. (4)

02 Mac-Chem Products(India)Pvt.Ltd (1)

03 Ajinomoto Omnichem (1)

04 AstraZeneca UK Ltd. (1)

05 Jeil Pharmaceutical Co., Ltd. (1)

06 Kyungbo Pharmaceutical Co., Ltd. (1)

07 Natco Pharma Limited (1)

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

02 AstraZeneca Korea Co., Ltd. (2)

03 Hanmi Pharmaceutical Co., Ltd. (1)

04 Ildong Pharmaceutical Co., Ltd. (1)

05 Jeil Pharmaceutical Co., Ltd. (1)

06 Kyungbo Pharmaceutical Co., Ltd. (1)

07 Masung LS Co., Ltd. (1)

08 Shinpoong Pharmaceutical Co., Ltd. (1)

09 UNUST Co., Ltd. (1)

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01 Gefitinib (10)

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01 India (6)

02 Japan (1)

03 South Korea (2)

04 United Kingdom (1)

URL Supplier Web Content
Ildong Pharmaceutical Co., Ltd.
2019-05-02
Number 6321-6-ND(3)
Mac-Chem Products (India)...
India
N-211/2/10. MIDC, Boisar,...
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Hanmi Pharmaceutical Co., Ltd.
2017-02-14
Number 6321-6-ND(2)
Mac-Chem Products (India)...
India
N-211/2/10. MIDC, Boisar,...
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Shinpoong Pharmaceutical Co., Ltd.
2016-08-24
Number 6321-6-ND(1)
Mac-Chem Products(India)P...
India
N-211/2/10. MIDC, Boisar....
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Masung LS Co., Ltd.
2020-08-05
Number 6321-6-ND(4)
Mac-Chem Products (India)...
India
N-211/2/10 MIDC, Tarapur,...
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UNUST Co., Ltd.
2015-03-06
Number 6321-6-ND
Mac-Chem Products (India)...
India
N-211/2/10 MIDC, Tarapur,...
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AstraZeneca Korea Co., Ltd.
2014-10-31
Number 3042-9-ND
Ajinomoto Omnichem
Belgium
Cooppallaan 91, Wetteren,...
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AstraZeneca Korea Co., Ltd.
2003-05-27
661-1-ND
AstraZeneca UK Ltd.
United Kingdom
Silk Road Business Park, ...
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Jeil Pharmaceutical Co., Ltd.
2014-02-07
1668-12-ND
Jeil Pharmaceutical Co., ...
South Korea
7, Cheongganggachang-ro, ...
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Kyungbo Pharmaceutical Co., Ltd.
2014-07-10
1673-13-ND
Kyungbo Pharmaceutical Co...
South Korea
174, Silok-ro, Asan-si, C...
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Aging Life Science Co., Ltd.
2018-11-23
Number 434-7-ND
Natco Pharma Limited
India
Mekaguda Village, Nandiga...
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Looking for 184475-35-2 / Gefitinib API manufacturers, exporters & distributors?

Gefitinib manufacturers, exporters & distributors 1

47

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 KDMF

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

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

After submitting a Irressat 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 Irressat API can apply through the Korea Drug Master File (KDMF).

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

Irressat Manufacturers | Traders | Suppliers

Irressat Manufacturers, Traders, Suppliers 1
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We have 6 companies offering Irressat

Get in contact with the supplier of your choice:

  1. Mac-Chem Products (India) Pvt.Ltd
  2. Ajinomoto Company
  3. AstraZeneca
  4. Jeil Pharmaceutical Co., Ltd
  5. Kyongbo Pharmaceutical Co., Ltd
  6. Natco Pharma
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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