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List of Drug Master Files (JDMF) for Pirfenidone Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 Dipharma Francis S. r. l. (1)

02 Rolabo Outsourcing,S. L. (1)

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

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01 Pirfenidone (3)

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01 Italy (1)

02 Mexico (1)

03 Spain (1)

URL Supplier Web Content
231MF10023
Via Bissone, 5, 20021-Baranzate, Mi...
2019-02-05
2019-02-05
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231MF10003
Poligono Industrial Malpica C/J, No...
2019-01-10
2019-01-10
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220MF10130
Av. Industria Automotriz No 301, Zo...
2021-07-09
2008-05-20
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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 JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Pirfenidone Drug Master File in Japan (Pirfenidone JDMF) empowers Pirfenidone API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Pirfenidone JDMF during the approval evaluation for pharmaceutical products. At the time of Pirfenidone JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Pirfenidone suppliers with JDMF on PharmaCompass.

Pirfenidone Manufacturers | Traders | Suppliers

Pirfenidone Manufacturers, Traders, Suppliers 1
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We have 3 companies offering Pirfenidone

Get in contact with the supplier of your choice:

  1. Dipharma
  2. Rolabo Outsourcing, S.L.
  3. Signa S.A. de C.V.
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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