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01 1Noramco

02 1CHONGQING LAND TOWER PHARMACEUTICAL CO

03 1Fujifilm Diosynth Biotechnologies

04 1Mallinckrodt Pharmaceuticals

05 1Merck & Co

06 1Saneca Pharmaceuticals

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PharmaCompass

01

  • fda
  • EDQM
  • WHO-GMP

Virtual BoothNoramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.

GDUFA

DMF Review : Complete

Rev. Date : 2016-04-23

Pay. Date : 2016-04-07

DMF Number : 22992

Submission : 2009-07-28

Status : Active

Type : II

Noramco

02

OPRD USA
Not Confirmed

02

04

OPRD USA
Not Confirmed

05

OPRD USA
Not Confirmed

Looking for 16590-41-3 / Naltrexone API manufacturers, exporters & distributors?

Naltrexone manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Naltrexone

Synonyms

16590-41-3, Vivitrol, Revia, N-cyclopropylmethylnoroxymorphone, Vivitrex, Celupan

Cas Number

16590-41-3

Unique Ingredient Identifier (UNII)

5S6W795CQM

About Naltrexone

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.

Naltrexone Manufacturers

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

Naltrexone Suppliers

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

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

Naltrexone USDMF

A Naltrexone DMF (Drug Master File) is a document detailing the whole manufacturing process of Naltrexone active pharmaceutical ingredient (API) in detail. Different forms of Naltrexone DMFs exist exist since differing nations have different regulations, such as Naltrexone USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Naltrexone DMF submitted to regulatory agencies in the US is known as a USDMF. Naltrexone USDMF includes data on Naltrexone's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Naltrexone USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Naltrexone suppliers with USDMF on PharmaCompass.

Naltrexone Manufacturers | Traders | Suppliers

Naltrexone Manufacturers, Traders, Suppliers 1
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.