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List of Drug Master Files (DMF) of Gefitinib Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Alembic Pharmaceuticals Limited (1)

02 Cipla (1)

03 Hetero Drugs (1)

04 MSN Laboratories (1)

05 Natco Pharma Limited (1)

06 Qilu Antibiotics Pharmaceutical Co., Ltd. (1)

07 SYNTHON Chemicals GmbH & Co. KG (1)

08 ScinoPharm Taiwan, Ltd (1)

09 Sichuan Xieli Pharmaceutical (1)

10 Yabao Pharmaceutical Group Co. Ltd (1)

11 Zhejiang Hisun Pharmaceutical (1)

12 Zhejiang Jiuzhou Pharmaceutical (1)

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01 GEFITINIB (11)

02 GEFITINIB [ROUTE CODE GN] (1)

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01 China (5)

02 Germany (1)

03 India (5)

04 Taiwan (1)

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01 Active (11)

02 Inactive (1)

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01 Complete (9)

02 Blank (3)

URL Supplier Web Content
30868
Active
2016-09-19
Complete
2016-12-13
2016-09-08
II
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URL Supplier Web Content
29090
Active
2015-03-23
Complete
2017-10-27
2017-09-13
II
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URL Supplier Web Content
32274
Active
2017-12-28
Complete
2018-02-23
2018-01-04
II
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URL Supplier Web Content
29670
Active
2015-09-04
Complete
2017-05-25
2016-09-30
II
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URL Supplier Web Content
29772
Active
2015-09-24
Complete
2016-02-11
2015-09-24
II
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URL Supplier Web Content
31941
Active
2017-08-31
N/A
II
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URL Supplier Web Content
26456
Active
2012-09-18
Complete
2016-07-05
2015-12-23
II
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URL Supplier Web Content
29797
Active
2015-11-17
Complete
2016-06-27
2015-11-19
II
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URL Supplier Web Content
28613
Active
2014-09-03
N/A
II
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URL Supplier Web Content
30518
Active
2016-04-28
Complete
2016-10-28
2016-06-15
II
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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.

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 USDMF

A Gefitinib DMF (Drug Master File) is a document detailing the whole manufacturing process of Gefitinib active pharmaceutical ingredient (API) in detail. Different forms of Gefitinib DMFs exist exist since differing nations have different regulations, such as Gefitinib USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Gefitinib DMF submitted to regulatory agencies in the US is known as a USDMF. Gefitinib USDMF includes data on Gefitinib's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Gefitinib USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Gefitinib suppliers with USDMF on PharmaCompass.

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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