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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**Federal Re...DOSAGE - SOLUTION;ORAL - 5MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET, EXTENDED RELEASE;ORAL - 325MG;7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 **Federal Re...DOSAGE - TABLET;ORAL - 325MG;5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 87003
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ABOUT THIS PAGE
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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 Oxiconum manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Oxiconum, including repackagers and relabelers. The FDA regulates Oxiconum manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Oxiconum 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 Oxiconum manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Oxiconum supplier is an individual or a company that provides Oxiconum active pharmaceutical ingredient (API) or Oxiconum finished formulations upon request. The Oxiconum suppliers may include Oxiconum API manufacturers, exporters, distributors and traders.
click here to find a list of Oxiconum suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Oxiconum DMF (Drug Master File) is a document detailing the whole manufacturing process of Oxiconum active pharmaceutical ingredient (API) in detail. Different forms of Oxiconum DMFs exist exist since differing nations have different regulations, such as Oxiconum USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Oxiconum DMF submitted to regulatory agencies in the US is known as a USDMF. Oxiconum USDMF includes data on Oxiconum's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Oxiconum USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Oxiconum 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 Oxiconum Drug Master File in Japan (Oxiconum JDMF) empowers Oxiconum 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 Oxiconum JDMF during the approval evaluation for pharmaceutical products. At the time of Oxiconum 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 Oxiconum 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 Oxiconum Drug Master File in Korea (Oxiconum KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Oxiconum. The MFDS reviews the Oxiconum KDMF as part of the drug registration process and uses the information provided in the Oxiconum KDMF to evaluate the safety and efficacy of the drug.
After submitting a Oxiconum 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 Oxiconum API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Oxiconum suppliers with KDMF on PharmaCompass.
A Oxiconum CEP of the European Pharmacopoeia monograph is often referred to as a Oxiconum Certificate of Suitability (COS). The purpose of a Oxiconum CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Oxiconum EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Oxiconum to their clients by showing that a Oxiconum CEP has been issued for it. The manufacturer submits a Oxiconum CEP (COS) as part of the market authorization procedure, and it takes on the role of a Oxiconum CEP holder for the record. Additionally, the data presented in the Oxiconum CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Oxiconum DMF.
A Oxiconum CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Oxiconum 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 Oxiconum suppliers with CEP (COS) on PharmaCompass.
A Oxiconum written confirmation (Oxiconum WC) is an official document issued by a regulatory agency to a Oxiconum manufacturer, verifying that the manufacturing facility of a Oxiconum active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Oxiconum APIs or Oxiconum finished pharmaceutical products to another nation, regulatory agencies frequently require a Oxiconum WC (written confirmation) as part of the regulatory process.
click here to find a list of Oxiconum 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 Oxiconum as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Oxiconum 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 Oxiconum 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 Oxiconum and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Oxiconum NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Oxiconum suppliers with NDC on PharmaCompass.
Oxiconum 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 Oxiconum 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 Oxiconum GMP manufacturer or Oxiconum GMP API supplier for your needs.
A Oxiconum CoA (Certificate of Analysis) is a formal document that attests to Oxiconum's compliance with Oxiconum specifications and serves as a tool for batch-level quality control.
Oxiconum CoA mostly includes findings from lab analyses of a specific batch. For each Oxiconum 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.
Oxiconum may be tested according to a variety of international standards, such as European Pharmacopoeia (Oxiconum EP), Oxiconum JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Oxiconum USP).
