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

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01 Sun Pharmaceutical Industries Limited (1)

02 Teva API (1)

03 Alembic Pharmaceuticals Limited (1)

04 Fresenius Kabi Oncology Limited (1)

05 Hetero Drugs (2)

06 MSN Laboratories (1)

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

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01 AFATINIB DIMALEATE (6)

02 AFATINIB DIMALEATE (FORM A) (1)

03 AFATINIB DIMALEATE MONOHYDRATE (FORM-R) (1)

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01 China (1)

02 India (6)

03 Israel (1)

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01 Active (8)

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01 Complete (6)

02 Blank (2)

URL Supplier Web Content
31515
Active
2017-05-31
Complete
2017-06-29
2017-04-28
II
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URL Supplier Web Content
31302
Active
2017-01-12
Complete
2017-02-28
2017-01-10
II
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URL Supplier Web Content
31848
Active
2017-06-30
Complete
2017-07-18
2017-06-27
II
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URL Supplier Web Content
30927
Active
2016-12-31
N/A
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URL Supplier Web Content
31611
Active
2017-04-11
Complete
2017-05-30
2017-04-28
II
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URL Supplier Web Content
37111
Active
2022-05-07
N/A
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URL Supplier Web Content
31285
Active
2016-12-31
Complete
2017-05-17
2017-03-24
II
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URL Supplier Web Content
33080
Active
2019-02-11
Complete
2019-03-21
2019-02-12
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Looking for 936631-70-8 / Afatinib API manufacturers, exporters & distributors?

Afatinib manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Afatinib

Synonyms

850140-73-7, Afatinib (dimaleate), Gilotrif, Afatinib maleate, Bibw 2992ma2, Giotrif

Cas Number

936631-70-8

Unique Ingredient Identifier (UNII)

V1T5K7RZ0B

About Afatinib

A quinazoline and butenamide derivative that acts as a tyrosine kinase inhibitor of epidermal growth factor receptors (ERBB RECEPTORS) and is used in the treatment of metastatic NON-SMALL CELL LUNG CANCER.

Afatinib Manufacturers

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

Afatinib Suppliers

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

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

Afatinib USDMF

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

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

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

Afatinib Manufacturers | Traders | Suppliers

Afatinib 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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