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List of Japan Drug Master File (JDMF) for ALTAVERA Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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218MF10848
Kloosterstraat 6, 5349 AB Oss, the ...
2007-07-26
2006-10-20
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218MF10829
Kaiser-Wilhelm-Allee 1,51373 Leverk...
2022-03-30
2006-10-20
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  • TABLET;ORAL-28 - 0.02MG;1MG
  • TABLET;ORAL-21 - 0.03MG;1.5MG
  • TABLET;ORAL-28 - 0.03MG;0.3MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL-21 - 0.03MG;1.5MG
  • TABLET;ORAL-21 - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL-28 - 0.035MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,1MG,0.5MG
  • TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL-28 - 0.035MG;0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL-28 - 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL-21 - 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL-21 - 0.15MG;0.03MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 0.02MG;1MG
  • TABLET;ORAL - 0.02MG,0.15MG;0.025MG,0.15MG;0.03MG,0.15MG;0.01MG,N/A
  • CAPSULE;ORAL - 0.02MG;1MG
  • TABLET, CHEWABLE, TABLET;ORAL - 0.01MG,0.01MG,N/A;1MG,N/A,N/A
  • TABLET;ORAL - 0.02MG;0.1MG
  • RING;VAGINAL - 0.013MG/24HR;0.15MG/24HR
  • TABLET;ORAL - 0.0025MG;0.5MG
  • TABLET;ORAL - 0.005MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL-28 - 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0.025MG
  • FILM, EXTENDED RELEASE;TRANSDERMAL - 0.035MG/24HR;0.15MG/24HR **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • RING;VAGINAL - 0.015MG/24HR;0.12MG/24HR
  • TABLET;ORAL-28 - 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 0.035MG;0.4MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 3MG;0.02MG
  • TABLET;ORAL - 0.02MG;1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 0.01MG,0.01MG;1MG,N/A
  • TABLET, CHEWABLE;ORAL - 0.025MG;0.8MG

Looking for 57-63-6 / Ethinyl Estradiol API manufacturers, exporters & distributors?

Ethinyl Estradiol manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ethinyl Estradiol

Synonyms

Ethynylestradiol, 57-63-6, Ethinylestradiol, Ethynyl estradiol, Ethinyloestradiol, 17-ethinylestradiol

Cas Number

57-63-6

Unique Ingredient Identifier (UNII)

423D2T571U

About Ethinyl Estradiol

A semisynthetic alkylated ESTRADIOL with a 17-alpha-ethinyl substitution. It has high estrogenic potency when administered orally, and is often used as the estrogenic component in ORAL CONTRACEPTIVES.

ALTAVERA Manufacturers

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

ALTAVERA Suppliers

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

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

ALTAVERA 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 ALTAVERA Drug Master File in Japan (ALTAVERA JDMF) empowers ALTAVERA 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 ALTAVERA JDMF during the approval evaluation for pharmaceutical products. At the time of ALTAVERA 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 ALTAVERA suppliers with JDMF on PharmaCompass.

ALTAVERA Manufacturers | Traders | Suppliers

ALTAVERA Manufacturers, Traders, Suppliers 1
54

We have 4 companies offering ALTAVERA

Get in contact with the supplier of your choice:

  1. Aspen API
  2. Bayer AG
  3. Laboratorios Leon Farma S.A.
  4. Zhejiang Xianju Junye Pharmaceutical Co. LTD
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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