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

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01 Gonane Pharma (1)

02 LGM Pharma (1)

03 HRV Global Life Sciences (1)

04 Acebright India Pharma Private Limited (1)

05 Alembic Pharmaceuticals Limited (2)

06 Anax Laboratories (1)

07 BDR Lifesciences (2)

08 Biotechnica DWC (1)

09 Brawn Laboratories Ltd (1)

10 Cdymax (1)

11 Cipla (1)

12 Estechpharma (1)

13 Farmhispania (1)

14 Fresenius Kabi Oncology Limited (1)

15 Fujian South Pharmaceutical (1)

16 Guangzhou Tosun Pharmaceutical (1)

17 Hetero Drugs (1)

18 Jeil Pharmaceutical Co., Ltd (1)

19 Jiwan Pharmaceutical Technology Co., Ltd (1)

20 KOLON Life Science, Inc (1)

21 Kekule Pharma (1)

22 Lunan Pharmaceutical (1)

23 MSN Laboratories (1)

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

25 NEWEDGE Overseas (1)

26 Natco Pharma (1)

27 Nishchem International Pvt. Ltd (1)

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

29 Qilu Pharmaceutical (1)

30 Reyoung pharmaceutical (1)

31 SYNTHON Chemicals GmbH & Co. KG (1)

32 Sakar Healthcare (1)

33 ScinoPharm Taiwan, Ltd (1)

34 Shandong Anhong Pharmaceutical (1)

35 Shouyuan Chemical (1)

36 Sichuan Xieli Pharmaceutical (1)

37 Synthland (1)

38 Synthon Pharmaceuticals (1)

39 Tecoland Corporation (1)

40 Vannsh Life Sciences (1)

41 Yabao Pharmaceutical Group Co. Ltd (1)

42 Yangtze River Pharmaceutical Group (1)

43 Zhejiang Hisun Pharmaceutical (1)

44 Zhejiang Huahai Pharmaceutical (1)

45 Zhejiang Jiuzhou Pharmaceutical (1)

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01 Algeria (1)

02 China (16)

03 Germany (1)

04 India (21)

05 Netherlands (1)

06 South Korea (3)

07 Spain (1)

08 Taiwan (1)

09 U.S.A (2)

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01 Active (11)

02 Inactive (1)

03 Blank (35)

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01 Valid (11)

02 Withdrawn by Holder (1)

03 Blank (35)

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01 229MF10151 (1)

02 229MF10197 (1)

03 229MF10200 (1)

04 230MF10026 (1)

05 230MF10029 (1)

06 Blank (42)

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01 WC-0014 (1)

02 WC-0041 (1)

03 WC-0082 (1)

04 WC-0082A8 (1)

05 WC-0115 (1)

06 WC-0138 (1)

07 WC-0275 (1)

08 WC-0340 (1)

09 WC-0349 (1)

10 WC-340n (1)

11 Blank (37)

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Application Number
Status
 
Filing Details
Issue/Submission Date
HRV Global Life Sciences Company Banner

Cophex 2024

Not Confirmed

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USDMF

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Application Number
26456
R0-CEP 2018-281 - Rev 00
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
GEFITINIB
Gefitinib
Issue/Submission Date
2012-09-18
2020-02-24
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USDMF

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CEP/COS

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Application Number
30518
R0-CEP 2018-236 - Rev 01
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
GEFITINIB
Gefitinib
Issue/Submission Date
2016-04-28
2022-02-02
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USDMF

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CEP/COS

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Written Confirmation

Found WC

Application Number
29670
CEP 2016-227 - Rev 02
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-05-05
Filing Details
GEFITINIB [ROUTE CODE GN]
Gefitinib
Gefitinib (IHS)
Issue/Submission Date
2015-09-04
2024-01-23
2022-09-02
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Caution WC

Application Number
29090
R1-CEP 2017-002 - Rev 00
Indian CDSCO WC-0138
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-08
Filing Details
GEFITINIB
Gefitinib
Gefitinib (IH)
Issue/Submission Date
2015-03-23
2023-03-24
2019-08-09
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USDMF

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CEP/COS

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Written Confirmation

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Application Number
30868
R0-CEP 2018-087 - Rev 00
Indian CDSCO WC-0082
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
GEFITINIB
Gefitinib
Gefitinib EP
Issue/Submission Date
2016-09-19
2019-02-05
2022-06-17
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Found WC

Application Number
32274
R0-CEP 2018-031 - Rev 00
230MF10026
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
GEFITINIB
Gefitinib
Gefitinib at 7-2-A2,Hetero Corporat...
Gefitinib (1H)
Issue/Submission Date
2017-12-28
2019-11-19
2018-02-15
2022-09-16
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USDMF

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Application Number
28613
Status
Active
Fees Paid
N/A
 
Filing Details
GEFITINIB
Issue/Submission Date
2014-09-03
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USDMF

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Application Number
29797
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
GEFITINIB
Issue/Submission Date
2015-11-17
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USDMF

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Application Number
29772
Status
Active
Fees Paid
Reviewed
 
Filing Details
GEFITINIB
Issue/Submission Date
2015-09-24
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USDMF

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Application Number
31941
Status
Active
Fees Paid
N/A
 
Filing Details
GEFITINIB
Issue/Submission Date
2017-08-31
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Application Number
27310
Status
Inactive
Fees Paid
N/A
 
Filing Details
GEFITINIB
Issue/Submission Date
2013-07-26
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USDMF

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Application Number
Indian CDSCO WC-340n
Status
 
Valid
2025-04-14
Filing Details
GEFTINIB IH
Issue/Submission Date
2022-09-30
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Application Number
Indian CDSCO WC-0340
Status
 
Expired
2022-04-14
Filing Details
Gefitinib
Issue/Submission Date
2019-07-22
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Application Number
Indian CDSCO WC-0115
Status
 
Expired
2022-07-07
Filing Details
Gefitinib IP/IH
Issue/Submission Date
2019-07-08
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Application Number
R1-CEP 2016-241 - Rev 00
Status
Valid
 
Filing Details
Gefitinib
Issue/Submission Date
2022-11-08
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Application Number
R0-CEP 2017-164 - Rev 00
Indian CDSCO WC-0275
Status
Withdrawn by Holder
 
Expired
2023-08-01
Filing Details
Gefitinib
Gefitinib
Issue/Submission Date
2019-03-27
2021-01-22
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Application Number
R1-CEP 2016-154 - Rev 00
229MF10200
Status
Valid
 
Filing Details
Gefitinib
Gefitinib at Brnenska 32/cp. 597 67...
Issue/Submission Date
2022-06-07
2017-11-14
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USDMF

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USDMF

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Application Number
Indian CDSCO WC-0082A8
Status
 
Expired
2022-07-02
Filing Details
GEFTINIB IH
Issue/Submission Date
2021-04-20
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Application Number
R1-CEP 2016-305 - Rev 00
230MF10029
Status
Valid
 
Filing Details
Gefitinib
Gefitinib at Balmes 85, Atico, 0800...
Issue/Submission Date
2022-10-06
2018-02-15
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Application Number
R1-CEP 2017-028 - Rev 00
Status
Valid
 
Filing Details
Gefitinib
Issue/Submission Date
2023-03-22
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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.

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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