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List of Korea Drug Master Files (KDMF) for Hydromorphone Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Sameung Industrial Co., Ltd.
2022-04-25
20220204-211-J-1228(A)
Macfarlan Smith Limited
United Kingdom
10 Wheatfield Road, Edinb...
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Baeksu Pharmaceutical Co., Ltd.
2022-02-04
20220204-211-J-1228
Macfarlan Smith Limited
United Kingdom
10 Wheatfield Road, Edinb...
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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  • TABLET, EXTENDED RELEASE;ORAL - 12MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 16MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 32MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 8MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Manufacturers

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

Hydromorphone Suppliers

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

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

Hydromorphone KDMF

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

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

After submitting a Hydromorphone 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 Hydromorphone API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Hydromorphone suppliers with KDMF on PharmaCompass.

Hydromorphone Manufacturers | Traders | Suppliers

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

Get in contact with the supplier of your choice:

  1. Veranova
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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