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Pluviaendo Naltrexone Hydrochloride Pluviaendo Naltrexone Hydrochloride

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List of Drug Master Files (KDMF) for Vivitrol Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

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01 Sanofi Winthrop Industries (1)

02 Rusan Pharma Ltd. (3)

03 Siegfried PharmaChemikalien Minden GmbH (1)

04 SpecGx LLC (1)

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01 Base Farm Co., Ltd. (1)

02 CTC Bio Co., Ltd. (1)

03 FarmChem Service Co., Ltd. (1)

04 Hiple Co., Ltd. (1)

05 Leesung International Co., Ltd. (1)

06 Samo Pharmaceutical Co., Ltd. (1)

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01 naltrexone hydrochloride (6)

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01 France (1)

02 India (3)

03 Ireland (1)

04 Switzerland (1)

Samo Pharmaceutical Co., Ltd.
2019-05-30
20190530-209-J-359
Sanofi Winthrop Industrie...
France
Route d'Avignon 30390 Ara...
FarmChem Service Co., Ltd.
2023-10-16
20210611-209-J-542(2)
Rusan Pharma Ltd.
India
Plot no. 6406, GIDC ESTAT...
Base Farm Co., Ltd.
2021-09-30
20210611-209-J-542(1)
Rusan Pharma Ltd.
India
Plot no. 6406, GIDC ESTAT...
Hiple Co., Ltd.
2021-06-11
20210611-209-J-542
Rusan Pharma Ltd.
India
Plot no. 6406, GIDC ESTAT...
URL Supplier Web Content
Leesung International Co., Ltd.
2021-03-31
20210331-209-J-569
SpecGx LLC
U.S.A
3600 North Second Street,...
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CTC Bio Co., Ltd.
2020-09-23
20200923-209-J-729
Siegfried PharmaChemikali...
Germany
Karlstraße 15-39, 42-44,...
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Looking for 16676-29-2 / Naltrexone Hydrochloride API manufacturers, exporters & distributors?

Naltrexone Hydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Naltrexone Hydrochloride

Synonyms

Naltrexone hcl, 16676-29-2, Trexan, Depade, Antaxone, Revia

Cas Number

16676-29-2

Unique Ingredient Identifier (UNII)

Z6375YW9SF

About Naltrexone Hydrochloride

Derivative of noroxymorphone that is the N-cyclopropylmethyl congener of NALOXONE. It is a narcotic antagonist that is effective orally, longer lasting and more potent than naloxone, and has been proposed for the treatment of heroin addiction. The FDA has approved naltrexone for the treatment of alcohol dependence.

Vivitrol Manufacturers

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

Vivitrol Suppliers

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

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

Vivitrol KDMF

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

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

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

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

Vivitrol Manufacturers | Traders | Suppliers

Vivitrol Manufacturers, Traders, Suppliers 1
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We have 4 companies offering Vivitrol

Get in contact with the supplier of your choice:

  1. EUROAPI
  2. Rusan Pharma
  3. Mallinckrodt Pharmaceuticals
  4. Siegfried AG
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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