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List of Japan Drug Master File (JDMF) for 08H Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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219MF10128
Koivu-Mankkaan tie 6A, FI-02200 Esp...
2023-09-20
2007-04-18
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Via Curiel 34, 20067 Paulo, Milano,...
2018-11-20
2006-08-14
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  • TABLET;ORAL - 0.25MG
  • TABLET;ORAL - 0.5MG
  • TABLET;ORAL - 1MG
  • TABLET;ORAL - 2MG
  • TABLET, EXTENDED RELEASE;ORAL - 0.5MG
  • TABLET, EXTENDED RELEASE;ORAL - 1MG
  • TABLET, EXTENDED RELEASE;ORAL - 2MG
  • TABLET, EXTENDED RELEASE;ORAL - 3MG

Looking for 28981-97-7 / Alprazolam API manufacturers, exporters & distributors?

Alprazolam manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Alprazolam

Synonyms

Xanax, 28981-97-7, Trankimazin, Niravam, Tafil, Tranquinal

Cas Number

28981-97-7

Unique Ingredient Identifier (UNII)

YU55MQ3IZY

About Alprazolam

A triazolobenzodiazepine compound with antianxiety and sedative-hypnotic actions, that is efficacious in the treatment of PANIC DISORDERS, with or without AGORAPHOBIA, and in generalized ANXIETY DISORDERS. (From AMA Drug Evaluations Annual, 1994, p238)

08H Manufacturers

A 08H manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of 08H, including repackagers and relabelers. The FDA regulates 08H manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. 08H 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 08H manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

08H Suppliers

A 08H supplier is an individual or a company that provides 08H active pharmaceutical ingredient (API) or 08H finished formulations upon request. The 08H suppliers may include 08H API manufacturers, exporters, distributors and traders.

click here to find a list of 08H suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

08H 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 08H Drug Master File in Japan (08H JDMF) empowers 08H 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 08H JDMF during the approval evaluation for pharmaceutical products. At the time of 08H 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 08H suppliers with JDMF on PharmaCompass.

08H Manufacturers | Traders | Suppliers

08H Manufacturers, Traders, Suppliers 1
42

We have 3 companies offering 08H

Get in contact with the supplier of your choice:

  1. Fermion Oy
  2. Cambrex Corporation
  3. Osaka Synthetic Chemical Laboratories
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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