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

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01 Dr. Reddy's Laboratories (2)

02 Shandong Boyuan Pharmaceutical (1)

03 Gonane Pharma (1)

04 Aarti Pharmalabs (1)

05 Zeon Pharma Industries India Pvt Ltd (1)

06 LGM Pharma (1)

07 HRV Global Life Sciences (1)

08 Acebright India Pharma Private Limited (1)

09 Apotex Pharmachem (1)

10 Archimica (1)

11 Aspen Biopharma Labs (1)

12 Aspire Lifesciences Pvt Ltd (1)

13 BDR Lifesciences (2)

14 Baran Chemical and Pharmaceutical (1)

15 Bo-Chem Pvt Ltd (1)

16 Cdymax (1)

17 Cipla (2)

18 Danesh Kimia Pharmed (1)

19 Divis Laboratories (1)

20 Fuan Pharmaceutical (1)

21 Fujian South Pharmaceutical (1)

22 Granules India Limited (1)

23 Guangzhou Tosun Pharmaceutical (1)

24 Hetero Drugs (1)

25 Intas Pharmaceuticals (2)

26 JIANGSU ZW PHARMACEUTICALS CO LTD (1)

27 Jiangsu Hengrui Medicine (1)

28 Jin Dun Medical (1)

29 Jiwan Pharmaceutical Technology Co., Ltd (1)

30 Kekule Pharma (1)

31 LIANYUNGANG GUIKE PHARMACEUTICAL CO., LTD. (1)

32 Laurus Labs (1)

33 Lunan Pharmaceutical (1)

34 MSN Laboratories (1)

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

36 NEWEDGE Overseas (1)

37 Nishchem International Pvt. Ltd (1)

38 Qilu Pharmaceutical (1)

39 Qilu Tianhe Pharmaceutical Co., Ltd. (2)

40 Qingdao Qingmei Biotech (1)

41 Reliance Life Sciences Private Limited (1)

42 Sakar Healthcare (1)

43 SciAnda (Changshu) Pharmaceutical (1)

44 ScinoPharm Taiwan, Ltd (1)

45 Shandong Anxin Pharmaceutical (1)

46 Shilpa Medicare (1)

47 Shouyuan Chemical (1)

48 Sichuan Xieli Pharmaceutical (1)

49 Signa S.A. de C.V. (1)

50 Stason Pharmaceuticals, Inc. (1)

51 Sumar Biotech (1)

52 Sun Pharmaceutical Industries Limited (1)

53 Suzhou Lixin Pharmaceutical (1)

54 Symed Labs (1)

55 Synthland (1)

56 Teva API (1)

57 Teva Pharmaceutical Industries (1)

58 Vannsh Life Sciences (1)

59 Viatris (1)

60 Zhejiang Cheng Yi Pharmaceutical Co., Ltd (1)

61 Zhejiang Hisun Pharmaceutical (1)

62 Zydus Lifesciences (1)

63 Zyphars Biopharmaceuticals (1)

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01 Canada (1)

02 China (22)

03 India (35)

04 Iran (2)

05 Israel (2)

06 Italy (1)

07 Mexico (1)

08 Taiwan (1)

09 U.S.A (3)

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01 Active (17)

02 Inactive (11)

03 Blank (40)

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01 Valid (16)

02 Withdrawn by Holder (4)

03 Blank (48)

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01 228MF10215 (1)

02 229MF10104 (1)

03 229MF10131 (1)

04 231MF10064 (1)

05 304MF10148 (1)

06 304MF10153 (1)

07 Blank (62)

filter

01 WC-0030 (1)

02 WC-0041 (1)

03 WC-0067A3-A4 (1)

04 WC-0067A4-5 (1)

05 WC-0099 (1)

06 WC-0113 (1)

07 WC-0128 (1)

08 WC-0138 (1)

09 WC-0147 (1)

10 WC-0157 (1)

11 WC-0159 (1)

12 WC-0198 (1)

13 WC-0213 (1)

14 WC-0275 (1)

15 WC-0327n (1)

16 WC-0340 (1)

17 WC-0349 (1)

18 WC-0484 (1)

19 WC-0526 (1)

20 WC-340n (1)

21 Blank (48)

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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Found WC

Application Number
22479
R1-CEP 2014-109 - Rev 02
304MF10153
Indian CDSCO WC-0067A4-5
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-07
Filing Details
CAPECITABINE USP
Capecitabine
Capecitabine at 8-2-337, Road No. 3...
Capecitabine EP
Issue/Submission Date
2009-01-30
2022-09-13
2022-12-07
2022-07-04
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
R1-CEP 2014-343 - Rev 01
Status
Valid
 
Filing Details
Capecitabine
Issue/Submission Date
2023-08-07
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
Status
 
Filing Details
Issue/Submission Date
See all info for this supplier

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USDMF

Found USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Application Number
22954
Indian CDSCO WC-0099
Status
Active
Fees Paid
N/A
 
Valid
2025-07-29
Filing Details
CAPECITABINE
Capecitabine USP
Issue/Submission Date
2009-07-17
2023-01-06
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USDMF

Close USDMF

CEP/COS

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Japanese DMF

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Written Confirmation

Close WC

Application Number
Status
 
Filing Details
Issue/Submission Date
Zeon Pharma Industries India Pvt Ltd Company Banner

Cophex 2024

Not Confirmed

envelop Contact Supplier
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USDMF

Close USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

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

Cophex 2024

Not Confirmed

envelop Contact Supplier
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USDMF

Close USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Application Number
R1-CEP 2014-203 - Rev 00
Indian CDSCO WC-0067A3-A4
Status
Valid
 
Valid
2025-07-07
Filing Details
Capecitabine
Capecitabine USP
Issue/Submission Date
2020-05-07
2022-06-13
URL Supplier Web Content
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Caution WC

Application Number
24689
R1-CEP 2014-332 - Rev 02
229MF10131
Indian CDSCO WC-0147
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-02
Filing Details
CAPECITABINE USP
Capecitabine
Capecitabine at Shilpa House, #12-6...
Capecitabine (1H)
Issue/Submission Date
2011-03-24
2023-02-07
2017-07-19
2019-07-05
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USDMF

Found USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
29209
Status
Active
Fees Paid
Reviewed
 
Filing Details
CAPECITABINE
Issue/Submission Date
2015-11-19
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USDMF

Found USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25266
Status
Active
Fees Paid
N/A
 
Filing Details
CAPECITABINE
Issue/Submission Date
2011-09-07
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Application Number
26018
R1-CEP 2016-140 - Rev 00
Indian CDSCO WC-0159
Status
Active
Fees Paid
N/A
Valid
 
Valid
2025-07-25
Filing Details
CAPECITABINE USP
Capecitabine
Capecitabine (USP)
Issue/Submission Date
2012-07-13
2022-09-08
2022-06-08
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US
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USDMF

Found USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Application Number
23808
Indian CDSCO WC-0198
Status
Active
Fees Paid
Reviewed
 
Valid
2025-07-21
Filing Details
CAPECITABINE USP
Capecitabine (USP/EP)
Issue/Submission Date
2010-05-25
2022-08-31
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Application Number
26078
R1-CEP 2015-391 - Rev 02
Indian CDSCO WC-0349
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-05-05
Filing Details
CAPECITABINE USP [ROUTE CODE - "CT"...
Capecitabine
Capecitabine (USP)
Issue/Submission Date
2012-05-22
2023-08-16
2022-09-02
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USDMF

Found USDMF

CEP/COS

Caution CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Application Number
27026
R0-CEP 2020-187 - Rev 00
Indian CDSCO WC-0275
Status
Active
Fees Unpaid
N/A
Withdrawn by Holder
 
Expired
2023-08-01
Filing Details
CAPECITABINE
Capecitabine
Capecitabine(USP)
Issue/Submission Date
2013-04-02
2022-06-15
2021-01-22
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USDMF

Found USDMF

CEP/COS

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Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
27085
Status
Active
Fees Paid
Reviewed
 
Filing Details
CAPECITABINE (NON-STERILE API)
Issue/Submission Date
2013-04-02
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Caution WC

Application Number
22157
R1-CEP 2015-111 - Rev 00
Indian CDSCO WC-0030
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-06-16
Filing Details
CAPECITABINE
Capecitabine
Capecitabine (USP/ Ph. Eur/IP)
Issue/Submission Date
2008-10-27
2021-04-16
2019-06-17
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
24126
CEP 2018-015 - Rev 01
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
CAPECITABINE
Capecitabine
Issue/Submission Date
2010-08-31
2024-03-20
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
24370
R1-CEP 2015-325 - Rev 01
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
CAPECITABINE USP
Capecitabine
Issue/Submission Date
2010-11-09
2022-06-24
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
33574
R0-CEP 2019-143 - Rev 01
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
CAPECITABINE USP (PROCESS II)
Capecitabine, Process II
Issue/Submission Date
2019-03-04
2022-06-27
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USDMF

Found USDMF

CEP/COS

Close CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
26818
Status
Active
Fees Unpaid
N/A
 
Filing Details
CAPECITABINE (NON-STERILE, BULK FOR...
Issue/Submission Date
2013-01-06
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USDMF

Found USDMF

CEP/COS

Found CEP/COS

Japanese DMF

Found JDMF

Written Confirmation

Found WC

Application Number
22140
R1-CEP 2014-355 - Rev 02
228MF10215
Indian CDSCO WC-0041
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-08
Filing Details
CAPECITABINE, USP
Capecitabine
Capecitabine at 7-2-A2,Hetero Corpo...
Capecitabine (IH/USP)
Issue/Submission Date
2008-10-27
2023-06-16
2016-11-09
2022-09-16
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USDMF

Caution USDMF

CEP/COS

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Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25592
Status
Inactive
Fees Paid
N/A
 
Filing Details
CAPECITABINE
Issue/Submission Date
2011-11-08
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USDMF

Caution USDMF

CEP/COS

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Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
25521
Status
Inactive
Fees Paid
N/A
 
Filing Details
CAPECITABINE USP, NON-STERILE, BULK...
Issue/Submission Date
2011-11-22
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USDMF

Caution USDMF

CEP/COS

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Japanese DMF

Found JDMF

Written Confirmation

Close WC

Application Number
24529
304MF10148
Status
Inactive
Fees Paid
N/A
 
Filing Details
CAPECITABINE (NON-STERILE API)
Capecitabine at No. 10678 Wenliang ...
Issue/Submission Date
2010-12-31
2022-11-16
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Close WC

Application Number
22014
Status
Inactive
Fees Unpaid
N/A
 
Filing Details
CAPECITABINE
Issue/Submission Date
2008-08-28
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USDMF

Caution USDMF

CEP/COS

Caution CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Found WC

Application Number
21620
R1-CEP 2014-136 - Rev 00
Indian CDSCO WC-0113
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Valid
2025-08-08
Filing Details
CAPECITABINE USP
Capecitabine
Capecitabine (USP/Ph.Eur)
Issue/Submission Date
2009-08-19
2020-04-30
2022-06-20
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USDMF

Caution USDMF

CEP/COS

Caution CEP/COS

Japanese DMF

Close JDMF

Written Confirmation

Close WC

Application Number
26993
R0-CEP 2015-009 - Rev 00
Status
Inactive
Fees Paid
N/A
Withdrawn by Holder
 
Filing Details
CAPECITABINE USP
Capecitabine
Issue/Submission Date
2013-03-29
2015-12-11
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

Close WC

Application Number
30543
Status
Inactive
Fees Paid
N/A
 
Filing Details
CAPECITABINE USP
Issue/Submission Date
2016-06-23
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USDMF

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CEP/COS

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Japanese DMF

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Written Confirmation

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Application Number
26403
Status
Inactive
Fees Paid
N/A
 
Filing Details
CAPECITABINE
Issue/Submission Date
2012-09-03
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Looking for 154361-50-9 / Capecitabine API manufacturers, exporters & distributors?

Capecitabine manufacturers, exporters & distributors 1

25

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

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

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

API | Excipient name

Capecitabine

Synonyms

154361-50-9, Xeloda, Capiibine, Capecitibine, Captabin, Capecytabine

Cas Number

154361-50-9

Unique Ingredient Identifier (UNII)

6804DJ8Z9U

About Capecitabine

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

Capecitabine Manufacturers

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

Capecitabine Suppliers

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

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

Capecitabine Manufacturers | Traders | Suppliers

Capecitabine Manufacturers, Traders, Suppliers 1
65

We have 63 companies offering Capecitabine

Get in contact with the supplier of your choice:

  1. Gonane Pharma
  2. Dr. Reddy's Laboratories
  3. Aarti Pharmalabs
  4. Zeon Pharma Industries India Pvt Ltd
  5. LGM Pharma
  6. HRV Global Life Sciences
  7. Shandong Boyuan Pharmaceutical
  8. Acebright India Pharma Private Limited
  9. Apotex Pharmachem
  10. Archimica
  11. Aspen Biopharma Labs
  12. Aspire Lifesciences Pvt Ltd
  13. Baran Chemical and Pharmaceutical
  14. BDR Lifesciences
  15. Bo-Chem Pvt Ltd
  16. Cdymax
  17. Cipla
  18. Danesh Kimia Pharmed
  19. Divis Laboratories
  20. Fuan Pharmaceutical
  21. Fujian South Pharmaceutical
  22. Granules India Limited
  23. Guangzhou Tosun Pharmaceutical
  24. Hetero Drugs
  25. Intas Pharmaceuticals
  26. Jiangsu Hengrui Medicine
  27. JIANGSU ZW PHARMACEUTICALS CO LTD
  28. Jin Dun Medical
  29. Jiwan Pharmaceutical Technology Co., Ltd
  30. Kekule Pharma
  31. Laurus Labs
  32. LIANYUNGANG GUIKE PHARMACEUTICAL CO., LTD.
  33. Lunan Pharmaceutical
  34. Mac-Chem Products (India) Pvt.Ltd
  35. MSN Laboratories
  36. NEWEDGE Overseas
  37. Nishchem International Pvt. Ltd
  38. Qilu Pharmaceutical
  39. Qilu Tianhe Pharmaceutical Co., Ltd.
  40. Qingdao Qingmei Biotech
  41. Reliance Life Sciences Private Limited
  42. Sakar Healthcare
  43. SciAnda (Changshu) Pharmaceutical
  44. ScinoPharm Taiwan, Ltd
  45. Shandong Anxin Pharmaceutical
  46. Shilpa Medicare
  47. Shouyuan Chemical
  48. Sichuan Xieli Pharmaceutical
  49. Signa S.A. de C.V.
  50. Stason Pharmaceuticals, Inc.
  51. Sumar Biotech
  52. Sun Pharmaceutical Industries Limited
  53. Suzhou Lixin Pharmaceutical
  54. Symed Labs
  55. Synthland
  56. Teva API
  57. Teva Pharmaceutical Industries
  58. Vannsh Life Sciences
  59. Viatris
  60. Zhejiang Cheng Yi Pharmaceutical Co., Ltd
  61. Zhejiang Hisun Pharmaceutical
  62. Zydus Lifesciences
  63. Zyphars Biopharmaceuticals
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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