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

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01 Farmhispania S. A. (1)

02 Hetero Labs Limited (1)

03 KOLON LIFE SCIENCE, INC. (1)

04 Natco Pharma Limited. (1)

05 Synthon s. r. o. (1)

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01 GEFITINIB (1)

02 Gefitinib (4)

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01 India (2)

02 Netherlands (1)

03 South Korea (1)

04 Spain (1)

URL Supplier Web Content
230MF10029
Balmes 85, Atico, 08008 (Barcelona)...
2018-02-15
2018-02-15
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URL Supplier Web Content
230MF10026
7-2-A2,Hetero Corporate,Industrial ...
2018-10-26
2018-02-15
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229MF10151
110, MAGOKDONG-RO, GANGSEO-GU, SEOU...
2017-08-04
2017-08-04
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229MF10197
Natco House, Road No. 2, Banjara Hi...
2021-09-02
2017-11-09
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229MF10200
Brnenska 32/cp. 597 678 01 Blansko ...
2021-10-21
2017-11-14
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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.

Gefitinib Manufacturers

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

Gefitinib Suppliers

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

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

Gefitinib 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 Gefitinib Drug Master File in Japan (Gefitinib JDMF) empowers Gefitinib 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 Gefitinib JDMF during the approval evaluation for pharmaceutical products. At the time of Gefitinib 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 Gefitinib suppliers with JDMF on PharmaCompass.

Gefitinib Manufacturers | Traders | Suppliers

Gefitinib Manufacturers, Traders, Suppliers 1
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We have 5 companies offering Gefitinib

Get in contact with the supplier of your choice:

  1. Farmhispania
  2. Hetero Drugs
  3. KOLON Life Science, Inc
  4. Natco Pharma Limited
  5. Synthon Pharmaceuticals
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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