Synopsis
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VMF
DRUG PRODUCT COMPOSITIONS0
Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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DOSAGE - CAPSULE;ORAL - 5MG
USFDA APPLICATION NUMBER - 200534
DOSAGE - SOLUTION;ORAL - 100MG/5ML
USFDA APPLICATION NUMBER - 200535
DOSAGE - SOLUTION;ORAL - 5MG/5ML
USFDA APPLICATION NUMBER - 200535
DOSAGE - SOLUTION;ORAL - 5MG/5ML **Federal Re...DOSAGE - SOLUTION;ORAL - 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 201194
DOSAGE - TABLET;ORAL - 5MG
USFDA APPLICATION NUMBER - 202080
DOSAGE - TABLET;ORAL - 7.5MG
USFDA APPLICATION NUMBER - 202080
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 325M...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 204031
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 13....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 13.5MG
USFDA APPLICATION NUMBER - 208090
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 18M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 18MG
USFDA APPLICATION NUMBER - 208090
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 27M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 27MG
USFDA APPLICATION NUMBER - 208090
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36M...DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36MG
USFDA APPLICATION NUMBER - 208090
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 9MG
USFDA APPLICATION NUMBER - 208090
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 10MG
USFDA APPLICATION NUMBER - 22272
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 15MG
USFDA APPLICATION NUMBER - 22272
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 20MG
USFDA APPLICATION NUMBER - 22272
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 30MG
USFDA APPLICATION NUMBER - 22272
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 40MG
USFDA APPLICATION NUMBER - 22272
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 60MG
USFDA APPLICATION NUMBER - 22272
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 80MG
USFDA APPLICATION NUMBER - 22272
DOSAGE - TABLET;ORAL - 325MG;5MG
USFDA APPLICATION NUMBER - 87003
Related Excipient Companies
EUROAPI
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ABOUT THIS PAGE
33
PharmaCompass offers a list of Oxycodone 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 Oxycodone Hydrochloride manufacturer or Oxycodone Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Oxycodone Hydrochloride manufacturer or Oxycodone Hydrochloride supplier.
PharmaCompass also assists you with knowing the Oxycodone Hydrochloride API Price utilized in the formulation of products. Oxycodone Hydrochloride API Price is not always fixed or binding as the Oxycodone Hydrochloride Price is obtained through a variety of data sources. The Oxycodone Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Oxycontin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxycontin, including repackagers and relabelers. The FDA regulates Oxycontin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxycontin 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 Oxycontin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxycontin supplier is an individual or a company that provides Oxycontin active pharmaceutical ingredient (API) or Oxycontin finished formulations upon request. The Oxycontin suppliers may include Oxycontin API manufacturers, exporters, distributors and traders.
click here to find a list of Oxycontin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxycontin DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxycontin active pharmaceutical ingredient (API) in detail. Different forms of Oxycontin DMFs exist exist since differing nations have different regulations, such as Oxycontin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxycontin DMF submitted to regulatory agencies in the US is known as a USDMF. Oxycontin USDMF includes data on Oxycontin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxycontin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxycontin suppliers with USDMF on PharmaCompass.
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 Oxycontin Drug Master File in Japan (Oxycontin JDMF) empowers Oxycontin 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 Oxycontin JDMF during the approval evaluation for pharmaceutical products. At the time of Oxycontin 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 Oxycontin suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Oxycontin Drug Master File in Korea (Oxycontin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oxycontin. The MFDS reviews the Oxycontin KDMF as part of the drug registration process and uses the information provided in the Oxycontin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Oxycontin 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 Oxycontin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Oxycontin suppliers with KDMF on PharmaCompass.
A Oxycontin CEP of the European Pharmacopoeia monograph is often referred to as a Oxycontin Certificate of Suitability (COS). The purpose of a Oxycontin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oxycontin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oxycontin to their clients by showing that a Oxycontin CEP has been issued for it. The manufacturer submits a Oxycontin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oxycontin CEP holder for the record. Additionally, the data presented in the Oxycontin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oxycontin DMF.
A Oxycontin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxycontin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Oxycontin suppliers with CEP (COS) on PharmaCompass.
A Oxycontin written confirmation (Oxycontin WC) is an official document issued by a regulatory agency to a Oxycontin manufacturer, verifying that the manufacturing facility of a Oxycontin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oxycontin APIs or Oxycontin finished pharmaceutical products to another nation, regulatory agencies frequently require a Oxycontin WC (written confirmation) as part of the regulatory process.
click here to find a list of Oxycontin suppliers with Written Confirmation (WC) on PharmaCompass.
National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Oxycontin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oxycontin API and other APIs are published in this directory by the FDA.
The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.
Pharmaceutical companies that manufacture Oxycontin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.
The NDC directory also contains data on finished compounded human drug products that contain Oxycontin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxycontin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oxycontin suppliers with NDC on PharmaCompass.
Oxycontin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Oxycontin GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Oxycontin GMP manufacturer or Oxycontin GMP API supplier for your needs.
A Oxycontin CoA (Certificate of Analysis) is a formal document that attests to Oxycontin's compliance with Oxycontin specifications and serves as a tool for batch-level quality control.
Oxycontin CoA mostly includes findings from lab analyses of a specific batch. For each Oxycontin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Oxycontin may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxycontin EP), Oxycontin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxycontin USP).
