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List of all Manufacturers, Suppliers & Exporters of Afatinib API listed on PharmaCompass with details of regulatory filings

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01 LGM Pharma (1)

02 Sun Pharmaceutical Industries Limited (1)

03 Beijing Mesochem Technology (1)

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

05 Teva API (1)

06 Alembic Pharmaceuticals Limited (2)

07 Artis Biotech (1)

08 Beijing Sjar Technology Development (1)

09 Biotechnica DWC (1)

10 Epoch Labs (1)

11 Fresenius Kabi Oncology Limited (1)

12 Guangzhou Tosun Pharmaceutical (1)

13 Hangzhou Longshine Bio-Tech (1)

14 Hetero Drugs (2)

15 Lunan Pharmaceutical (1)

16 MSN Laboratories (1)

17 Natco Pharma (1)

18 Ningbo Zhenlei Chemical Co.,Ltd (1)

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

20 Sakar Healthcare (1)

21 Shilpa Medicare (1)

22 Shouyuan Chemical (1)

23 Teva Pharmaceutical Industries (1)

24 Vannsh Life Sciences (1)

25 Yangtze River Pharmaceutical Group (1)

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01 Algeria (1)

02 China (9)

03 India (14)

04 Israel (2)

05 U.S.A (1)

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01 Active (8)

02 Blank (19)

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01 Blank (27)

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01 Blank (27)

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01 WC-0041 (1)

02 WC-0041A3 (1)

03 WC-0082 (1)

04 WC-0082A8 (1)

05 WC-0115A3 (1)

06 WC-0349 (1)

07 Blank (21)

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USDMF

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Application Number
31515
Status
Active
Fees Paid
Reviewed
 
Filing Details
AFATINIB DIMALEATE
Issue/Submission Date
2017-05-31
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USDMF

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Application Number
31302
Status
Active
Fees Paid
Reviewed
 
Filing Details
AFATINIB DIMALEATE
Issue/Submission Date
2017-01-12
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USDMF

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Application Number
31285
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
 
Valid
2025-05-05
Filing Details
AFATINIB DIMALEATE MONOHYDRATE (FOR...
Afatinib Dimaleate IHS
Issue/Submission Date
2016-12-31
2022-09-02
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Application Number
31611
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
 
Valid
2025-08-08
Filing Details
AFATINIB DIMALEATE
Afatinib Dimaleate IH
Issue/Submission Date
2017-04-11
2022-09-16
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USDMF

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Caution WC

Application Number
37111
Indian CDSCO WC-0041A3
Status
Active
Fees Paid
N/A
 
Expired
2022-08-08
Filing Details
AFATINIB DIMALEATE (FORM A)
Afatinib Dimaleate IH
Issue/Submission Date
2022-05-07
2019-09-03
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USDMF

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Application Number
30927
Indian CDSCO WC-0115A3
Status
Active
Fees Paid
N/A
 
Valid
2025-09-15
Filing Details
AFATINIB DIMALEATE
Afatinib Dimaleate IH
Issue/Submission Date
2016-12-31
2022-09-30
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USDMF

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Application Number
33080
Status
Active
Fees Paid
Reviewed
 
Filing Details
AFATINIB DIMALEATE
Issue/Submission Date
2019-02-11
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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.

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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