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List of all Manufacturers, Suppliers & Exporters of NCGC00024992-03 API listed on PharmaCompass with details of regulatory filings

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01 Metrochem API Private Limited (1)

02 Veranova (1)

03 LGM Pharma (1)

04 HRV Global Life Sciences (1)

05 Alembic Pharmaceuticals Limited (3)

06 Allastir (1)

07 Amoli Organics (1)

08 Apotex Inc (1)

09 Apotex Pharmachem (1)

10 Aspire Lifesciences Pvt Ltd (1)

11 Aurobindo Pharma Limited (1)

12 Beijing Fukangren Biopharmaceutical (1)

13 CHEMO (1)

14 CHEMO IBERICA SA (1)

15 Cambrex Corporation (1)

16 Chemeca Drugs (1)

17 Cipla (1)

18 DEAFARMA (1)

19 Dipharma (1)

20 Glenmark Life Sciences (1)

21 Glenmark Pharmaceuticals (1)

22 Granules India Limited (1)

23 Guangzhou Tosun Pharmaceutical (1)

24 HONOUR LAB LTD (1)

25 Hetero Drugs (1)

26 Hubei Vanz Pharm (1)

27 IIQUIAP (1)

28 Jubilant Generics (1)

29 Laboratori Alchemia Srl (1)

30 Laurus Labs (1)

31 Lupin Ltd (1)

32 MSN Laboratories (1)

33 Macleods Pharmaceuticals Limited (1)

34 Maiden Group (1)

35 Mehta API (1)

36 Micro Labs Limited (1)

37 NEWEDGE Overseas (1)

38 Natco Pharma Limited (1)

39 Optimus Pharma (1)

40 Prajna Generics (1)

41 Procos (1)

42 Prudence Pharma Chem (1)

43 Raks Pharma (1)

44 Rolabo Outsourcing, S.L. (1)

45 SIMS Srl (1)

46 SMS Pharmaceuticals (1)

47 Shilpa Medicare (1)

48 Shivalik Rasayan (1)

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

50 Tyche Industries Ltd (1)

51 ULKAR KIMYA SANAYII VE TICARET (1)

52 Viatris (1)

53 Xian Libang Pharmaceutical Co.,Ltd (1)

54 ZCL Chemicals Limited (1)

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01 Canada (2)

02 China (4)

03 India (35)

04 Italy (5)

05 Mexico (2)

06 Spain (3)

07 Turkey (1)

08 U.S.A (4)

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01 Active (24)

02 Inactive (1)

03 Blank (31)

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01 Valid (20)

02 Blank (36)

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01 220MF10130 (1)

02 231MF10003 (1)

03 231MF10023 (1)

04 Blank (53)

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01 WC-0014A3 (1)

02 WC-0024 (1)

03 WC-0049 (1)

04 WC-0077A3 (1)

05 WC-0082 (1)

06 WC-0082A11 (1)

07 WC-0082A5 (1)

08 WC-0120 (1)

09 WC-0142 (1)

10 WC-0148 (1)

11 WC-0195 (1)

12 WC-0225A3 (1)

13 WC-0231 (1)

14 WC-0310 (1)

15 WC-0383 (1)

16 WC-0395A1 (1)

17 WC-0482 (1)

18 Blank (39)

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USDMF

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Application Number
32680
Status
Active
Fees Paid
Reviewed
 
Filing Details
PIRFENIDONE
Issue/Submission Date
2018-03-30
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USDMF

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

Biotechgate Digital

Not Confirmed

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USDMF

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CEP/COS

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Application Number
32423
R0-CEP 2018-096 - Rev 00
Indian CDSCO WC-0142
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-08-04
Filing Details
PIRFENIDONE
Pirfenidone
Pirfenidone (IH)
Issue/Submission Date
2018-03-22
2020-10-05
2022-06-17
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USDMF

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Application Number
32304
Status
Active
Fees Paid
Reviewed
 
Filing Details
PIRFENIDONE
Issue/Submission Date
2017-12-21
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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
30952
R1-CEP 2016-242 - Rev 00
Indian CDSCO WC-0148
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-02
Filing Details
PIRFENIDONE
Pirfenidone
Pirfenidone EP
Issue/Submission Date
2016-09-20
2022-10-03
2019-07-05
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USDMF

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Written Confirmation

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Application Number
31815
R0-CEP 2020-073 - Rev 00
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
PIRFENIDONE
Pirfenidone
Issue/Submission Date
2017-07-31
2021-10-28
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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
32772
R0-CEP 2018-147 - Rev 01
Indian CDSCO WC-0082
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
PIRFENIDONE
Pirfenidone
Pirfenidone IH/EP
Issue/Submission Date
2018-06-28
2023-02-01
2022-06-17
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USDMF

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Application Number
31274
Status
Active
Fees Paid
N/A
 
Filing Details
PIRFENIDONE
Issue/Submission Date
2016-12-31
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USDMF

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Application Number
32224
231MF10023
Status
Active
Fees Paid
Reviewed
 
Filing Details
PIRFENIDONE
Pirfenidone at Via Bissone, 5, 2002...
Issue/Submission Date
2018-04-24
2019-02-05
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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
30351
R0-CEP 2017-109 - Rev 02
Indian CDSCO WC-0049
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-16
Filing Details
PIRFENIDONE
Pirfenidone
Pirfenidone Ph.Eur
Issue/Submission Date
2016-04-13
2023-03-07
2022-06-07
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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
29700
R1-CEP 2016-122 - Rev 00
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
PIRFENIDONE
Pirfenidone
Issue/Submission Date
2015-11-04
2022-10-19
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USDMF

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Application Number
32657
R0-CEP 2021-077 - Rev 00
Status
Active
Fees Paid
Reviewed
Valid
 
Filing Details
PIRFENIDONE
Pirfenidone
Issue/Submission Date
2018-04-03
2022-06-20
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USDMF

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Application Number
37925
Status
Active
Fees Paid
N/A
 
Filing Details
PIRFENIDONE
Issue/Submission Date
2022-12-31
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USDMF

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CEP/COS

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Written Confirmation

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Application Number
30922
R1-CEP 2016-288 - Rev 00
Indian CDSCO WC-0024
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-06-28
Filing Details
PIRFENIDONE
Pirfenidone
Pirfenidone IH/EP
Issue/Submission Date
2016-09-30
2022-12-05
2022-07-08
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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
32796
R0-CEP 2018-127 - Rev 01
Status
Active
Fees Unpaid
Reviewed
Valid
 
Filing Details
PIRFENIDONE
Pirfenidone
Issue/Submission Date
2018-05-18
2021-10-14
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USDMF

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CEP/COS

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Written Confirmation

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Application Number
32201
CEP 2017-259 - Rev 02
Indian CDSCO WC-0195
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-07-02
Filing Details
PIRFENIDONE
Pirfenidone
Pirfenidone BP/EP
Issue/Submission Date
2017-10-28
2023-10-04
2019-06-17
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USDMF

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Japanese DMF

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Written Confirmation

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Application Number
31264
Indian CDSCO WC-0383
Status
Active
Fees Paid
Reviewed
 
Expired
2022-08-08
Filing Details
PIRFENIDONE
Pirfenidone IH/EP
Issue/Submission Date
2016-12-31
2019-07-26
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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
32696
CEP 2018-098 - Rev 02
Indian CDSCO WC-0120
Status
Active
Fees Paid
Reviewed
Valid
 
Valid
2025-07-02
Filing Details
PIRFENIDONE
Pirfenidone
Pirfenidone Ph.Eur
Issue/Submission Date
2018-04-13
2023-12-13
2022-07-15
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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
31072
R0-CEP 2017-170 - Rev 02
Indian CDSCO WC-0310
Status
Active
Fees Unpaid
Reviewed
Valid
 
Expired
2023-11-23
Filing Details
PIRFENIDONE
Pirfenidone
Pirfenidonee (Ph.Eur)
Issue/Submission Date
2016-11-30
2022-12-05
2021-01-08
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USDMF

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Written Confirmation

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Application Number
32384
R0-CEP 2018-091 - Rev 02
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
PIRFENIDONE
Pirfenidone
Issue/Submission Date
2018-01-24
2022-08-23
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USDMF

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Application Number
15168
220MF10130
Status
Active
Fees Paid
Reviewed
 
Filing Details
PIRFENIDONE EP
Pirfenidone at Av. Industria Automo...
Issue/Submission Date
2000-11-30
2008-05-20
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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
33599
R0-CEP 2019-067 - Rev 00
Indian CDSCO WC-0077A3
Status
Active
Fees Paid
N/A
Valid
 
Expired
2022-08-12
Filing Details
PIRFENIDONE
Pirfenidone
Pirfenidone EP
Issue/Submission Date
2019-02-19
2020-06-08
2020-03-09
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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
32739
R0-CEP 2019-062 - Rev 01
Indian CDSCO WC-0395A1
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2020-03-22
Filing Details
PIRFENIDONE
Pirfenidone
Pirfenidone (EP/IHS)
Issue/Submission Date
2018-05-04
2023-04-11
2019-03-05
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USDMF

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Application Number
32654
R0-CEP 2019-155 - Rev 01
Indian CDSCO WC-0225A3
Status
Active
Fees Paid
Reviewed
Valid
 
Expired
2022-08-15
Filing Details
PIRFENIDONE
Pirfenidone
Pirfenidone EP
Issue/Submission Date
2018-04-03
2022-11-16
2020-01-16
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USDMF

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Application Number
32015
R0-CEP 2018-007 - Rev 01
Status
Active
Fees Paid
N/A
Valid
 
Filing Details
PIRFENIDONE
Pirfenidone
Issue/Submission Date
2017-09-23
2022-03-30
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Application Number
5170
Status
Inactive
Fees Paid
N/A
 
Filing Details
PIRFENIDONE
Issue/Submission Date
1983-11-24
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Application Number
CEP 2021-413 - Rev 00
Status
Valid
 
Filing Details
Pirfenidone
Issue/Submission Date
2024-01-05
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Application Number
R0-CEP 2018-260 - Rev 00
231MF10003
Status
Valid
 
Filing Details
Pirfenidone
Pirfenidone at Poligono Industrial ...
Issue/Submission Date
2020-06-26
2019-01-10
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Looking for 53179-13-8 / Pirfenidone API manufacturers, exporters & distributors?

Pirfenidone manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Pirfenidone

Synonyms

53179-13-8, 5-methyl-1-phenylpyridin-2(1h)-one, Esbriet, Amr-69, Deskar, Pirespa

Cas Number

53179-13-8

Unique Ingredient Identifier (UNII)

D7NLD2JX7U

About Pirfenidone

Pirfenidone is an orally active synthetic antifibrotic agent structurally similar to pyridine 2,4-dicarboxylate. Pirfenidone inhibits fibroblast, epidermal, platelet-derived, and transforming beta-1 growth factors, thereby slowing tumor cell proliferation. This agent also inhibits DNA synthesis and the production of mRNA for collagen types I and III, resulting in a reduction in radiation-induced fibrosis. (NCI04)

NCGC00024992-03 Manufacturers

A NCGC00024992-03 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of NCGC00024992-03, including repackagers and relabelers. The FDA regulates NCGC00024992-03 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. NCGC00024992-03 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 NCGC00024992-03 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

NCGC00024992-03 Suppliers

A NCGC00024992-03 supplier is an individual or a company that provides NCGC00024992-03 active pharmaceutical ingredient (API) or NCGC00024992-03 finished formulations upon request. The NCGC00024992-03 suppliers may include NCGC00024992-03 API manufacturers, exporters, distributors and traders.

click here to find a list of NCGC00024992-03 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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