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
Veranova: A CDMO that manages complexity with confidence.
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Temad- We think of world-class quality.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
CEP/COS 
NDC
KDMF
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
Veranova: A CDMO that manages complexity with confidence.
Veranova: A CDMO that manages complexity with confidence.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
CEP/COS
NDC
KDMF
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
NDC
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USDMF
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34028
Submission : 2019-10-14
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 32506
Submission : 2018-03-16
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2014-06-21
Pay. Date : 2014-06-13
DMF Number : 18472
Submission : 2005-06-30
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-15
Pay. Date : 2012-11-23
DMF Number : 21353
Submission : 2008-02-21
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-27
Pay. Date : 2012-11-23
DMF Number : 20975
Submission : 2007-10-26
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2013-04-16
Pay. Date : 2013-04-05
DMF Number : 16399
Submission : 2003-02-03
Status :
Type : II
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Veranova: A CDMO that manages complexity with confidence.
Certificate Number : CEP 2005-036 - Rev 04
Status : Valid
Issue Date : 2024-04-10
Type : Chemical
Substance Number : 1793
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Certificate Number : CEP 2008-249 - Rev 04
Status : Valid
Issue Date : 2025-10-20
Type : Chemical
Substance Number : 1793
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
Certificate Number : R1-CEP 2011-284 - Rev 02
Status : Valid
Issue Date : 2021-02-24
Type : Chemical
Substance Number : 1793
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
Certificate Number : R1-CEP 2009-058 - Rev 04
Status : Valid
Issue Date : 2022-05-12
Type : Chemical
Substance Number : 1793
Siegfried – A global CDMO delivering integrated pharmaceutical development and manufacturing solutions.
Certificate Number : R1-CEP 2006-001 - Rev 01
Status : Valid
Issue Date : 2018-11-21
Type : Chemical
Substance Number : 1793
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]API Reference Price
API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
Drugs in Development
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]INTERMEDIATE SUPPLIERS
Temad- We think of world-class quality.
CAS Number : 115-37-7
End Use API : Oxycodone Hydrochloride
About The Company : Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. ...
Temad- We think of world-class quality.
CAS Number : 467-13-0
End Use API : Oxycodone Hydrochloride
About The Company : Temad Co., established in 1997, is one of Iran's largest API producers and an innovative manufacturer of narcotic and non-narcotic products in the Middle East. ...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Oxycodone Hydrochloride; Naloxone Hydrochloride Anhydrous
Brand Name : Oxycodone Naloxone Zentiva mg
Dosage Form : Modified Release Tablet
Dosage Strength : 10mg;5mg
Packaging :
Approval Date : 18/08/2023
Application Number : 69126
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Oxycodone Hydrochloride; Naloxone Hydrochloride Anhydrous
Brand Name : Oxycodone Naloxone Zentiva mg
Dosage Form : Modified Release Tablet
Dosage Strength : 20mg;10mg
Packaging :
Approval Date : 18/08/2023
Application Number : 69126
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Oxycodone Hydrochloride; Naloxone Hydrochloride Anhydrous
Brand Name : Oxycodone Naloxone Zentiva mg
Dosage Form : Modified Release Tablet
Dosage Strength : 40mg;20mg
Packaging :
Approval Date : 18/08/2023
Application Number : 69126
Regulatory Info : Allowed
Registration Country : Switzerland
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Allowed
Registration Country : Switzerland
Oxycodone Hydrochloride; Naloxone Hydrochloride Anhydrous
Brand Name : Oxycodone Naloxone Zentiva
Dosage Form : Prolonged Release Tablet
Dosage Strength : 5mg;2.5mg
Packaging :
Approval Date : 18/08/2023
Application Number : 69126
Regulatory Info : Allowed
Registration Country : Switzerland
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Oxycodone Depot Orion
Dosage Form : Tablet
Dosage Strength : 10mg
Packaging :
Approval Date : 16/12/2013
Application Number : 20120830000026
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Oxycodone Depot Orion
Dosage Form : Tablet
Dosage Strength : 20mg
Packaging :
Approval Date : 16/12/2013
Application Number : 20120830000040
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Oxycodone Depot Orion
Dosage Form : Tablet
Dosage Strength : 30mg
Packaging :
Approval Date : 16/12/2013
Application Number : 20120830000057
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Oxycodone Depot Orion
Dosage Form : Tablet
Dosage Strength : 5mg
Packaging :
Approval Date : 16/12/2013
Application Number : 20120830000019
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Oxycodone Depot Orion
Dosage Form : Tablet
Dosage Strength : 60mg
Packaging :
Approval Date : 16/12/2013
Application Number : 20120830000071
Regulatory Info : Approved
Registration Country : Sweden
Regulatory Info : Approved
Registration Country : Sweden
Brand Name : Oxycodone Depot Orion
Dosage Form : Tablet
Dosage Strength : 80mg
Packaging :
Approval Date : 16/12/2013
Application Number : 20120830000088
Regulatory Info : Approved
Registration Country : Sweden
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FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
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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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
89
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 ROXICET-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of ROXICET-1, including repackagers and relabelers. The FDA regulates ROXICET-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. ROXICET-1 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 ROXICET-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A ROXICET-1 supplier is an individual or a company that provides ROXICET-1 active pharmaceutical ingredient (API) or ROXICET-1 finished formulations upon request. The ROXICET-1 suppliers may include ROXICET-1 API manufacturers, exporters, distributors and traders.
click here to find a list of ROXICET-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A ROXICET-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of ROXICET-1 active pharmaceutical ingredient (API) in detail. Different forms of ROXICET-1 DMFs exist exist since differing nations have different regulations, such as ROXICET-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A ROXICET-1 DMF submitted to regulatory agencies in the US is known as a USDMF. ROXICET-1 USDMF includes data on ROXICET-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The ROXICET-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of ROXICET-1 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 ROXICET-1 Drug Master File in Japan (ROXICET-1 JDMF) empowers ROXICET-1 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 ROXICET-1 JDMF during the approval evaluation for pharmaceutical products. At the time of ROXICET-1 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 ROXICET-1 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 ROXICET-1 Drug Master File in Korea (ROXICET-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of ROXICET-1. The MFDS reviews the ROXICET-1 KDMF as part of the drug registration process and uses the information provided in the ROXICET-1 KDMF to evaluate the safety and efficacy of the drug.
After submitting a ROXICET-1 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 ROXICET-1 API can apply through the Korea Drug Master File (KDMF).
click here to find a list of ROXICET-1 suppliers with KDMF on PharmaCompass.
A ROXICET-1 CEP of the European Pharmacopoeia monograph is often referred to as a ROXICET-1 Certificate of Suitability (COS). The purpose of a ROXICET-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of ROXICET-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of ROXICET-1 to their clients by showing that a ROXICET-1 CEP has been issued for it. The manufacturer submits a ROXICET-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a ROXICET-1 CEP holder for the record. Additionally, the data presented in the ROXICET-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the ROXICET-1 DMF.
A ROXICET-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. ROXICET-1 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 ROXICET-1 suppliers with CEP (COS) on PharmaCompass.
A ROXICET-1 written confirmation (ROXICET-1 WC) is an official document issued by a regulatory agency to a ROXICET-1 manufacturer, verifying that the manufacturing facility of a ROXICET-1 active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting ROXICET-1 APIs or ROXICET-1 finished pharmaceutical products to another nation, regulatory agencies frequently require a ROXICET-1 WC (written confirmation) as part of the regulatory process.
click here to find a list of ROXICET-1 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 ROXICET-1 as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for ROXICET-1 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 ROXICET-1 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 ROXICET-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a ROXICET-1 NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of ROXICET-1 suppliers with NDC on PharmaCompass.
ROXICET-1 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 ROXICET-1 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 ROXICET-1 GMP manufacturer or ROXICET-1 GMP API supplier for your needs.
A ROXICET-1 CoA (Certificate of Analysis) is a formal document that attests to ROXICET-1's compliance with ROXICET-1 specifications and serves as a tool for batch-level quality control.
ROXICET-1 CoA mostly includes findings from lab analyses of a specific batch. For each ROXICET-1 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.
ROXICET-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (ROXICET-1 EP), ROXICET-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (ROXICET-1 USP).
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