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

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2007-02-13
2006-04-27
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2006-08-11
2006-08-11
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2010-12-24
2010-12-24
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2009-06-16
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Looking for 3916-18-5 / Droxidopa API manufacturers, exporters & distributors?

Droxidopa manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Droxidopa

Synonyms

23651-95-8, L-dops, Dops, Northera, 3916-18-5, (2s,3r)-2-amino-3-(3,4-dihydroxyphenyl)-3-hydroxypropanoic acid

Cas Number

3916-18-5

Unique Ingredient Identifier (UNII)

24A0V01WKS

About Droxidopa

A synthetic precursor of norepinephrine that is used in the treatment of PARKINSONIAN DISORDERS and ORTHOSTATIC HYPOTENSION.

Northera Manufacturers

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

Northera Suppliers

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

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

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

Northera Manufacturers | Traders | Suppliers

Northera Manufacturers, Traders, Suppliers 1
43

We have 2 companies offering Northera

Get in contact with the supplier of your choice:

  1. Chongqing Shenghuaxi Pharma. Co., Ltd
  2. Estechpharma
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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