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List of Drug Master Files (KDMF) for Dienogest Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Bayer AG, "Bergkamen" (undifferentiated: Bayer AG, "Berlin-Charlottenburg") (1)

02 Chemo Biosynthesis srl@Industriale Chimica srl (1)

03 INDUSTRIALE CHIMICA srl (3)

04 NEWCHEM SpA@Microchem Srl (1)

05 Newchem SpA@[Microchemical Manufacturing Company] Microchem SRL (1)

06 Sterling SPA@Microchem SRL (1)

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01 Aging Life Science Co., Ltd. (1)

02 Bayer Korea Co., Ltd. (1)

03 Darim Biotech Co., Ltd. (1)

04 Dongkook Pharmaceutical Co., Ltd. (1)

05 Hanwha Pharmaceutical Co., Ltd. (1)

06 Korea Pharmbio Co., Ltd. (1)

07 Shinpoong Pharmaceutical Co., Ltd. (1)

08 Sungjin Exim Co., Ltd. (1)

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01 Dieno Guest (6)

02 Dienogest (micronized) (1)

03 Micronized dienogest (1)

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01 Germany (1)

02 Italy (7)

URL Supplier Web Content
Bayer Korea Co., Ltd.
2011-05-16
Wed2420-4-ND
Bayer AG, "Bergkamen" (un...
Germany
Bergkamen Plant: Ernst-Sc...
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Aging Life Science Co., Ltd.
2023-09-14
Number 434-58-ND
Chemo Biosynthesis srl@In...
Italy
Via per Voghera, 1 - 2705...
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Hanwha Pharmaceutical Co., Ltd.
2018-10-28
Number 236-1-ND(2)
INDUSTRIALE CHIMICA srl
Italy
Via EH Grieg, 13, 21047, ...
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Shinpoong Pharmaceutical Co., Ltd.
2018-08-14
Number 236-1-ND(1)
INDUSTRIALE CHIMICA srl
Italy
Via EH Grieg, 13, 21047, ...
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Korea Pharmbio Co., Ltd.
2018-07-04
Number 236-1-ND
INDUSTRIALE CHIMICA srl
Italy
Via EH Grieg, 13, 21047, ...
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Sungjin Exim Co., Ltd.
2021-05-24
Number 437-1-ND(1)
NEWCHEM SpA@Microchem Srl
Italy
Via Roveggia, 47-37136 VE...
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Dongkook Pharmaceutical Co., Ltd.
2020-02-13
Number 437-1-ND
Newchem SpA@[Microchemica...
Italy
Via Roveggia, 47-37136 Ve...
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Darim Biotech Co., Ltd.
2019-02-11
Number 242-1-ND
Sterling SPA@Microchem SR...
Italy
Via della Carboneria 30 (...
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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 KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Dienogest Drug Master File in Korea (Dienogest KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Dienogest. The MFDS reviews the Dienogest KDMF as part of the drug registration process and uses the information provided in the Dienogest KDMF to evaluate the safety and efficacy of the drug.

After submitting a Dienogest KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Dienogest API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Dienogest suppliers with KDMF 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. Bayer AG
  2. Chemo Biosynthesis
  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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