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

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01 Heyl Chemisch-pharmazeutische Fabrik GmbH & Co. K.G. (1)

02 INDUSTRIALE CHIMICA s. r. l. (1)

03 Sterling S. p. A. (1)

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01 Dienogest (3)

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01 Austria (1)

02 Italy (2)

URL Supplier Web Content
227MF10213
Via E. H. Grieg, 13,21047 Saronno (...
2020-09-17
2015-08-31
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URL Supplier Web Content
228MF10027
Kurfu(¨)rstendamm 178-179 10707 Be...
2016-02-02
2016-02-02
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URL Supplier Web Content
228MF10063
Via Della Carboneria 30 Solomeo 060...
2016-02-24
2016-02-24
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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 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 Dienogest Drug Master File in Japan (Dienogest JDMF) empowers Dienogest 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 Dienogest JDMF during the approval evaluation for pharmaceutical products. At the time of Dienogest 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 Dienogest suppliers with JDMF on PharmaCompass.

Dienogest Manufacturers | Traders | Suppliers

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

Get in contact with the supplier of your choice:

  1. Industriale Chimica s.r.l.
  2. PHARMAZEUTISCHE FABRIK MONTAVIT GES M.B.H.
  3. 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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