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

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01 Boehringer Ingelheim Pharma GmbH & Co. K.G. (1)

02 MSN Laboratories Private Limited (2)

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01 Boehringer Ingelheim Korea Co., Ltd. (1)

02 Grace Farm (1)

03 Pharmapia Co., Ltd. (1)

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01 Afatinib dimaleate (3)

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01 Germany (1)

02 India (2)

URL Supplier Web Content
Boehringer Ingelheim Korea Co., Ltd.
2013-09-27
Wed2807-4-ND
Boehringer Ingelheim Phar...
Germany
Binger Straße 173, D-552...
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URL Supplier Web Content
Grace Farm
2022-04-26
Number 674-3-ND
MSN Laboratories Private ...
India
(Unit-II), Sy.No.50, Kard...
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URL Supplier Web Content
Pharmapia Co., Ltd.
2022-08-08
Number 674-3-ND(1)
MSN Laboratories Private ...
India
(Unit-II), Sy.No.50, Kard...
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Looking for 936631-70-8 / Afatinib API manufacturers, exporters & distributors?

Afatinib manufacturers, exporters & distributors 1

51

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 KDMF

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

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

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

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

Afatinib Manufacturers | Traders | Suppliers

Afatinib Manufacturers, Traders, Suppliers 1
82

We have 2 companies offering Afatinib

Get in contact with the supplier of your choice:

  1. Boehringer Ingelheim GmbH
  2. MSN Laboratories
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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