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List of Drug Master Files (DMF) of Pirfenidone Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 Veranova (1)

02 Alembic Pharmaceuticals Limited (1)

03 Amoli Organics (1)

04 Aurobindo Pharma Limited (1)

05 CHEMO IBERICA SA (1)

06 Cipla (1)

07 Dipharma (1)

08 Glenmark Life Sciences (1)

09 Granules India Limited (1)

10 HONOUR LAB LTD (1)

11 Jubilant Generics (1)

12 Laurus Labs (1)

13 Lupin Ltd (1)

14 MSN Laboratories (1)

15 Macleods Pharmaceuticals Limited (1)

16 Micro Labs Limited (1)

17 Optimus Pharma (1)

18 Procos (1)

19 Raks Pharma (1)

20 SIMS Srl (1)

21 SMS Pharmaceuticals (1)

22 Shilpa Medicare (1)

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

24 Viatris (1)

25 ZCL Chemicals Limited (1)

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01 PIRFENIDONE (24)

02 PIRFENIDONE EP (1)

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01 India (18)

02 Italy (3)

03 Mexico (1)

04 Spain (1)

05 U.S.A (2)

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01 Active (24)

02 Inactive (1)

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01 Complete (18)

02 Blank (7)

32680
Active
2018-03-30
Complete
2018-04-27
2018-03-30
II
URL Supplier Web Content
31072
Active
2016-11-30
Complete
2017-04-21
2017-03-13
II
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URL Supplier Web Content
30922
Active
2016-09-30
Complete
2018-09-19
2018-08-03
II
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URL Supplier Web Content
29700
Active
2015-11-04
Complete
2015-12-18
2015-09-08
II
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URL Supplier Web Content
30351
Active
2016-04-13
Complete
2017-03-31
2016-09-22
II
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URL Supplier Web Content
31264
Active
2016-12-31
Complete
2018-04-20
2018-03-14
II
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URL Supplier Web Content
31815
Active
2017-07-31
N/A
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URL Supplier Web Content
30952
Active
2016-09-20
Complete
2017-01-13
2016-09-20
II
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URL Supplier Web Content
15168
Active
2000-11-30
Complete
2018-07-13
2018-05-25
II
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URL Supplier Web Content
31274
Active
2016-12-31
N/A
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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)

Pirfenidone Manufacturers

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

Pirfenidone Suppliers

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

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

Pirfenidone USDMF

A Pirfenidone DMF (Drug Master File) is a document detailing the whole manufacturing process of Pirfenidone active pharmaceutical ingredient (API) in detail. Different forms of Pirfenidone DMFs exist exist since differing nations have different regulations, such as Pirfenidone USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Pirfenidone DMF submitted to regulatory agencies in the US is known as a USDMF. Pirfenidone USDMF includes data on Pirfenidone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Pirfenidone USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Pirfenidone suppliers with USDMF 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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