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List of Certificates of Suitability (CEPs) for Dienogest Active Pharmaceutical Ingredient issued by the EDQM and listed on PharmaCompass.com

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R0-CEP 2020-023 - Rev 00
Valid
Chemical
2022-05-03
2732
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R1-CEP 2016-333 - Rev 00
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Chemical
2023-01-20
2732
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CEP 2016-155 - Rev 01
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2023-10-13
2732
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R1-CEP 2016-158 - Rev 00
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2023-08-02
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Looking for 65928-58-7 / Dienogest API manufacturers, exporters & distributors?

Dienogest manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Dienogest

Synonyms

65928-58-7, Dienogestrel, Dienogestril, Sts 557, Endometrion, Dienogestum

Cas Number

65928-58-7

Unique Ingredient Identifier (UNII)

46M3EV8HHE

About Dienogest

Dienogest is an orally-active, semisynthetic, fourth generation, nonethinylated progestogen with antiproliferative, antiandrogenic, anti-inflammatory and antiangiogenic activities that is used in hormone therapy and as a female contraceptive. Upon oral administration, dienogest binds intracellular progesterone receptors which then translocate to the nucleus where the drug-receptor complex interacts with progesterone response elements, thus altering the expression of target genes. Dienogest reduces the production of estradiol, prevents ovulation and alters the cervical mucus and endometrium. In addition, dienogest appears to suppress the expression of cell cycle regulator cyclin D1. Altogether, this may prevent the growth of endometrial epithelial cells and may reduce symptoms associated with leiomyoma.

Dienogest Manufacturers

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

Dienogest Suppliers

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

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

Dienogest CEP

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

A Dienogest CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Dienogest 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 Dienogest suppliers with CEP (COS) on PharmaCompass.

Dienogest Manufacturers | Traders | Suppliers

Dienogest Manufacturers, Traders, Suppliers 1
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We have 5 companies offering Dienogest

Get in contact with the supplier of your choice:

  1. Hubei Gedian Humanwell Pharmaceutical
  2. Gedeon Richter
  3. Industriale Chimica s.r.l.
  4. NEWCHEM SPA
  5. Sterling Spa
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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