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

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227MF10256
3-5-1 Nihonbashi Honmachi, Chuo-ku,...
2017-02-08
2015-10-21
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  • INJECTABLE;INJECTION - 0.2MG/ML
  • INJECTABLE;INJECTION - 0.5MG/0.5ML
  • INJECTABLE;INJECTION - 10MG/ML
  • INJECTABLE;INJECTION - 1MG/ML
  • INJECTABLE;INJECTION - 2MG/ML
  • INJECTABLE;INJECTION - 4MG/ML
  • SOLUTION;ORAL - 5MG/5ML
  • TABLET;ORAL - 2MG
  • TABLET;ORAL - 4MG
  • TABLET;ORAL - 8MG
  • TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 71-68-1 / Hydromorphone Hydrochloride API manufacturers, exporters & distributors?

Hydromorphone Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Hydromorphone Hydrochloride

Synonyms

71-68-1, Hydromorphone hcl, Dilaudid, Palladone, Hymorphan, Exalgo

Cas Number

71-68-1

Unique Ingredient Identifier (UNII)

L960UP2KRW

About Hydromorphone Hydrochloride

An opioid analgesic made from MORPHINE and used mainly as an analgesic. It has a shorter duration of action than morphine.

Hydromorphone Hydrochloride Manufacturers

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

Hydromorphone Hydrochloride Suppliers

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

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

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

Hydromorphone Hydrochloride Manufacturers | Traders | Suppliers

Hydromorphone Hydrochloride Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Hydromorphone Hydrochloride

Get in contact with the supplier of your choice:

  1. Daiichi Sankyo
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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