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List of Certificates of Suitability (CEPs) for Pirfenidone Active Pharmaceutical Ingredient (API) issued by the EDQM. Original Data: EDQM Database

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01 ALEMBIC PHARMACEUTICALS LIMITED Vadodara IN (1)

02 AMOLI ORGANICS PRIVATE LIMITED Mumbai IN (1)

03 APITORIA PHARMA PRIVATE LIMITED Hyderabad IN (1)

04 CHEMO IBERICA S.A. Madrid ES (1)

05 CIPLA LIMITED Mumbai IN (1)

06 Cambrex Profarmaco Milano S.r.l. Paullo IT (1)

07 GLENMARK LIFE SCIENCES LIMITED Mumbai IN (1)

08 GRANULES INDIA LIMITED Hyderabad IN (1)

09 HONOUR LAB LIMITED Hyderabad IN (1)

10 JUBILANT PHARMOVA LIMITED Nanjangud IN (1)

11 LAURUS LABS LIMITED Hyderabad IN (1)

12 LUPIN LIMITED Mumbai IN (1)

13 MACLEODS PHARMACEUTICALS LIMITED Mumbai IN (1)

14 MICRO LABS LIMITED Bengaluru IN (1)

15 OPTIMUS DRUGS PRIVATE LIMITED Hyderabad IN (1)

16 Procos S.P.A. Cameri IT (1)

17 ROLABO OUTSOURCING, S.L. Zaragoza ES (1)

18 SHILPA PHARMA LIFESCIENCES LIMITED Raichur IN (1)

19 SHIVALIK RASAYAN LIMITED New Delhi IN (1)

20 ZCL CHEMICALS LTD. Ankleshwar IN (1)

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01 Pirfenidone (20)

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01 India (16)

02 Italy (1)

03 Spain (2)

04 U.S.A (1)

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01 Valid (20)

URL Supplier Web Content
R0-CEP 2019-067 - Rev 00
Valid
Chemical
2020-06-08
2856
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R0-CEP 2018-091 - Rev 02
Valid
Chemical
2022-08-23
2856
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R0-CEP 2017-109 - Rev 02
Valid
Chemical
2023-03-07
2856
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R0-CEP 2021-077 - Rev 00
Valid
Chemical
2022-06-20
2856
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R0-CEP 2019-155 - Rev 01
Valid
Chemical
2022-11-16
2856
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R0-CEP 2018-007 - Rev 01
Valid
Chemical
2022-03-30
2856
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R0-CEP 2020-073 - Rev 00
Valid
Chemical
2021-10-28
2856
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R0-CEP 2018-260 - Rev 00
Valid
Chemical
2020-06-26
2856
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CEP 2021-413 - Rev 00
Valid
Chemical
2024-01-05
2856
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CEP 2017-259 - Rev 02
Valid
Chemical
2023-10-04
2856
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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 CEP

A Pirfenidone CEP of the European Pharmacopoeia monograph is often referred to as a Pirfenidone Certificate of Suitability (COS). The purpose of a Pirfenidone CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Pirfenidone EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Pirfenidone to their clients by showing that a Pirfenidone CEP has been issued for it. The manufacturer submits a Pirfenidone CEP (COS) as part of the market authorization procedure, and it takes on the role of a Pirfenidone CEP holder for the record. Additionally, the data presented in the Pirfenidone CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Pirfenidone DMF.

A Pirfenidone CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Pirfenidone CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Pirfenidone suppliers with CEP (COS) 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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