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

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01 Minakem (1)

02 Aarti Pharmalabs (1)

03 Polpharma (1)

04 Dr. Reddy's Laboratories (2)

05 Suanfarma (1)

06 Supriya Lifescience (1)

07 LGM Pharma (1)

08 Minakem (formerly Delmar Chemicals) (1)

09 Sichuan Elixir Pharmaceuticals (1)

10 Tofigh Daru (1)

11 Egis Pharmaceuticals PLC (1)

12 Acebright India Pharma Private Limited (1)

13 Alembic Pharmaceuticals Limited (2)

14 Anhui HaiKang Pharmaceutical (1)

15 Aurobindo Pharma Limited (1)

16 Baran Chemical and Pharmaceutical (1)

17 Beijing Hope Pharmaceutical (1)

18 Bulat Pharmaceutical (1)

19 Cdymax (1)

20 Cipla (1)

21 DEAFARMA (1)

22 Esteve Huayi Pharmaceutical (1)

23 Fresenius Kabi Oncology Limited (1)

24 Fujian South Pharmaceutical (1)

25 Guangzhou Tosun Pharmaceutical (1)

26 Hangzhou Longshine Bio-Tech (1)

27 Haoyuan Chemexpress Co.Ltd (1)

28 Hetero Drugs (1)

29 Hikma Pharmaceuticals (1)

30 MSN Laboratories (4)

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

32 Morepen Laboratories (1)

33 NEWEDGE Overseas (1)

34 Natco Pharma Limited (1)

35 ScinoPharm Taiwan, Ltd (1)

36 Shenzhen Haorui (1)

37 Shilpa Medicare (1)

38 Sichuan Qingmu Pharmaceutical (1)

39 Sun Pharmaceutical Industries Limited (1)

40 Teva API (1)

41 Teva Pharmaceutical Industries (1)

42 Vannsh Life Sciences (1)

43 Viatris (1)

44 Wisdom Pharmaceutical Co., Ltd. (2)

45 Zhejiang Ausun Pharmaceutical (1)

46 Zhejiang Tianyu Pharmaceutical Co., Ltd (1)

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01 Canada (1)

02 China (14)

03 France (1)

04 Hungary (1)

05 India (24)

06 Iran (2)

07 Israel (2)

08 Italy (1)

09 Poland (1)

10 Spain (1)

11 Taiwan (1)

12 U.S.A (2)

13 United Kingdom (1)

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01 Active (18)

02 Inactive (1)

03 Blank (33)

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01 Blank (52)

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01 Blank (52)

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01 WC-0082 (1)

02 WC-0082A5 (1)

03 WC-0115A3 (1)

04 WC-0349 (1)

05 WC-0390 (1)

06 Blank (47)

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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
31792
Indian CDSCO WC-0390
Status
Active
Fees Paid
N/A
 
Valid
2025-11-30
Filing Details
IBRUTINIB
Ibrutinib IH
Issue/Submission Date
2017-06-23
2022-07-28
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USDMF

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Application Number
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USDMF

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Application Number
Status
 
Filing Details
Issue/Submission Date
Minakem Delmar

CPhI Japan

Not Confirmed

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USDMF

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Application Number
37311
Status
Active
Fees Paid
N/A
 
Filing Details
IBRUTINIB (FORM-A)
Issue/Submission Date
2022-11-01
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USDMF

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Application Number
32122
Status
Active
Fees Paid
Reviewed
 
Filing Details
IBRUTINIB
Issue/Submission Date
2017-10-04
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USDMF

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Application Number
37000
Status
Active
Fees Unpaid
N/A
 
Filing Details
IBRUTINIB
Issue/Submission Date
2022-03-25
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USDMF

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Japanese DMF

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Written Confirmation

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Application Number
32880
Indian CDSCO WC-0082
Status
Active
Fees Paid
Reviewed
 
Valid
2025-07-02
Filing Details
IBRUTINIB
Ibrutinib IH
Issue/Submission Date
2018-07-02
2022-06-17
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USDMF

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Application Number
31679
Status
Active
Fees Paid
Reviewed
 
Filing Details
IBRUTINIB
Issue/Submission Date
2017-05-05
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USDMF

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Application Number
31917
Status
Active
Fees Unpaid
N/A
 
Filing Details
IBRUTINIB
Issue/Submission Date
2017-07-20
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USDMF

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Application Number
38919
Status
Active
Fees Unpaid
Reviewed
 
Filing Details
IBRUTINIB
Issue/Submission Date
2023-09-26
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USDMF

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Application Number
32937
Status
Active
Fees Paid
Reviewed
 
Filing Details
IBRUTINIB (IBN)
Issue/Submission Date
2018-08-17
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USDMF

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Application Number
31689
Status
Active
Fees Paid
Reviewed
 
Filing Details
IBRUTINIB (FORM-A)
Issue/Submission Date
2017-08-01
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USDMF

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Application Number
31547
Status
Active
Fees Paid
Reviewed
 
Filing Details
IBRUTINIB (FORM S4)
Issue/Submission Date
2017-09-08
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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
30557
Indian CDSCO WC-0349
Status
Active
Fees Paid
N/A
 
Valid
2025-05-05
Filing Details
IBRUTINIB (AMORPHOUS)
Ibrutinib IHS
Issue/Submission Date
2016-05-31
2022-09-02
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USDMF

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Application Number
30759
Status
Active
Fees Paid
N/A
 
Filing Details
IBRUTINIB (FORM-A)
Issue/Submission Date
2016-07-31
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USDMF

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Application Number
33357
Status
Active
Fees Paid
N/A
 
Filing Details
IBRUTINIB (FORM C)
Issue/Submission Date
2018-12-01
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USDMF

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Written Confirmation

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Application Number
34768
Status
Active
Fees Paid
N/A
 
Filing Details
IBRUTINIB (FORM-M5)
Issue/Submission Date
2020-09-07
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USDMF

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Application Number
31631
Status
Active
Fees Paid
Reviewed
 
Filing Details
IBRUTINIB
Issue/Submission Date
2017-06-08
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USDMF

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Application Number
30925
Status
Active
Fees Paid
Reviewed
 
Filing Details
IBRUTINIB
Issue/Submission Date
2016-12-23
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USDMF

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Written Confirmation

Found WC

Application Number
31199
Indian CDSCO WC-0115A3
Status
Active
Fees Paid
N/A
 
Valid
2025-09-15
Filing Details
IBRUTINIB
Ibrutinib IH
Issue/Submission Date
2017-05-12
2022-09-30
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USDMF

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Application Number
31728
Status
Inactive
Fees Paid
N/A
 
Filing Details
IBRUTINIB
Issue/Submission Date
2017-07-03
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USDMF

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Application Number
Indian CDSCO WC-0082A5
Status
 
Expired
2022-07-02
Filing Details
Ibrutinib IH
Issue/Submission Date
2019-10-22
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Looking for 936563-96-1 / Ibrutinib API manufacturers, exporters & distributors?

Ibrutinib manufacturers, exporters & distributors 1

100

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

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

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

API | Excipient name

Ibrutinib

Synonyms

936563-96-1, Pci-32765, Imbruvica, Pci 32765, Ibrutinib (pci-32765), Pci-32765 (ibrutinib)

Cas Number

936563-96-1

Unique Ingredient Identifier (UNII)

1X70OSD4VX

About Ibrutinib

Ibrutinib is an orally bioavailable, small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity. Upon oral administration, ibrutinib binds to and irreversibly inhibits BTK activity, thereby preventing both B-cell activation and B-cell-mediated signaling. This leads to an inhibition of the growth of malignant B cells that overexpress BTK. BTK, a member of the src-related BTK/Tec family of cytoplasmic tyrosine kinases, is required for B cell receptor signaling, plays a key role in B-cell maturation, and is overexpressed in a number of B-cell malignancies. The expression of BTK in tumor cells is also associated with increased proliferation and survival.

Ibrutinib Manufacturers

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

Ibrutinib Suppliers

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

click here to find a list of Ibrutinib 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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