Veranova Fentanyl Citrate Veranova Fentanyl Citrate

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

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Baeksu Pharmaceutical Co., Ltd.
2021-06-22
20210622-210-J-918
Macfarlan Smith Limited
United Kingdom
10 Wheatfield Road, Edinb...
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Sameung Industrial Co., Ltd.
2021-06-22
20210622-210-J-918(A)
Macfarlan Smith Limited
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10 Wheatfield Road, Edinb...
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Nosa Chemical Co., Ltd.
2021-04-05
20210405-210-J-919
Saneca Pharmaceuticals as
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Sameung Industrial Co., Ltd.
2022-02-15
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Yichang Humanwell Pharmac...
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  • TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.2MG BASE
  • TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.4MG BASE
  • TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.6MG BASE
  • TROCHE/LOZENGE;TRANSMUCOSAL - EQ 0.8MG BASE
  • TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.2MG BASE
  • TROCHE/LOZENGE;TRANSMUCOSAL - EQ 1.6MG BASE
  • TABLET;BUCCAL, SUBLINGUAL - EQ 0.1MG BASE
  • TABLET;BUCCAL, SUBLINGUAL - EQ 0.2MG BASE
  • TABLET;BUCCAL, SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;BUCCAL, SUBLINGUAL - EQ 0.4MG BASE
  • TABLET;BUCCAL, SUBLINGUAL - EQ 0.6MG BASE
  • TABLET;BUCCAL, SUBLINGUAL - EQ 0.8MG BASE
  • TABLET;SUBLINGUAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;SUBLINGUAL - EQ 0.2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;SUBLINGUAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;SUBLINGUAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;SUBLINGUAL - EQ 0.6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;SUBLINGUAL - EQ 0.8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SPRAY, METERED;NASAL - EQ 0.1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SPRAY, METERED;NASAL - EQ 0.3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • SPRAY, METERED;NASAL - EQ 0.4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 990-73-8 / Fentanyl Citrate API manufacturers, exporters & distributors?

Fentanyl Citrate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Fentanyl Citrate

Synonyms

990-73-8, Leptanal, Phentanyl citrate, Actiq, Fentanyl dihydrogen citrate, Abstral

Cas Number

990-73-8

Unique Ingredient Identifier (UNII)

MUN5LYG46H

About Fentanyl Citrate

A potent narcotic analgesic, abuse of which leads to habituation or addiction. It is primarily a mu-opioid agonist. Fentanyl is also used as an adjunct to general anesthetics, and as an anesthetic for induction and maintenance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1078)

Fentanyl Citrate Manufacturers

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

Fentanyl Citrate Suppliers

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

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

Fentanyl Citrate KDMF

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

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

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

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

Fentanyl Citrate Manufacturers | Traders | Suppliers

Fentanyl Citrate Manufacturers, Traders, Suppliers 1
98

We have 3 companies offering Fentanyl Citrate

Get in contact with the supplier of your choice:

  1. Veranova
  2. Saneca Pharmaceuticals
  3. Yichang Humanwell Pharmaceutical
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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