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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
About the Company : Faran Shimi Pharmaceutical Company, established in 2001 and affiliated with Golrang Pharmaceutical Investment Co, manufactures high-quality Active Pharmaceutical Ingredients (APIs)...
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
About the Company : Founded in 1979, Noramco specializes in the development and manufacturing of APIs for both opioid and non-opioid products. With expertise in controlled substance development and ma...
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
About the Company : SCI Pharmtech Inc. offers APIs, advanced intermediates, and custom products, focusing on quick development and cost-effective production. Our research labs, pilot plants, and produ...
Temad- We think of world-class quality.
About the Company : Established in 1997, Temad Co. is one of the largest producers of APIs in Iran & an innovative manufacturer of narcotic and non-narcotic products of world-class quality in the Midd...
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
About the Company : EUROAPI is the market leader in small molecule APIs with projected sales of about €1 billion in 2022. With around 200 APIs, it has one of the largest portfolios in the market. Th...
Veranova: A CDMO that manages complexity with confidence.
About the Company : Veranova is a global leader in the development and manufacturing of specialist and complex APIs for pharma and biotech customers. We have over 50 years of experience navigating the...
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
About the Company : Rusan Pharma is a fully integrated global pharmaceutical company specializing in the treatment of addiction & pain management. We manufacture & market a wide range of APIs & formul...
Parand Darou is a knowledge-based company, focused on the production of Narcotic APIs.
About the Company : Parand Daro Pharmaceutical Company is a knowledge-based company that commenced operations in 2015, focusing on the production of narcotic medicinal substances. Parand Daro holds th...
TAPI offers customized CDMO Solutions for API development and manufacturing services.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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Drugs in Development
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Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Regulatory Info :
Registration Country : India
Buprenorphine Hydrochloride; Naloxone Hydrochloride
Brand Name :
Dosage Form : Sublingual Tablet
Dosage Strength : 2MG; 0.5MG
Packaging : Pack Size 10x10; 1x7; 1x10
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Regulatory Info :
Registration Country : India
Buprenorphine Hydrochloride; Naloxone Hydrochloride
Brand Name :
Dosage Form : Sublingual Tablet
Dosage Strength : 8MG; 2MG
Packaging : Pack Size 10x10; 1x7; 1x10
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Sublingual Tablet
Dosage Strength : 0.2mg
Packaging : Pack Size 5x20; 1x7; 1x10
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Sublingual Tablet
Dosage Strength : 0.4mg
Packaging : Pack Size 3x10; 1x7; 1x10; 5x20
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Sublingual Tablet
Dosage Strength : 2mg
Packaging : Pack Size 4x7; 10x10; 1x7; 1x10
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Regulatory Info :
Registration Country : India
Brand Name :
Dosage Form : Sublingual Tablet
Dosage Strength : 8mg
Packaging : Pack Size 4x7; 10x10; 1x7; 1x10
Approval Date :
Application Number :
Regulatory Info :
Registration Country : India
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Oral Lyophilizate
Dosage Strength : 2MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Oral Lyophilizate
Dosage Strength : 8MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Sublingual Tablet
Dosage Strength : 4MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : France
Brand Name :
Dosage Form : Sublingual Tablet
Dosage Strength : 6MG
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : France
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DRUG PRODUCT COMPOSITIONS
DOSAGE - INJECTABLE;INJECTION - EQ 0.3MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 18401
DOSAGE - IMPLANT;IMPLANTATION - EQ 80MG BASE/...DOSAGE - IMPLANT;IMPLANTATION - EQ 80MG BASE/IMPLANT
USFDA APPLICATION NUMBER - 204442
DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG...DOSAGE - FILM;BUCCAL - EQ 2.1MG BASE;EQ 0.3MG BASE
USFDA APPLICATION NUMBER - 205637
DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG...DOSAGE - FILM;BUCCAL - EQ 4.2MG BASE;EQ 0.7MG BASE
USFDA APPLICATION NUMBER - 205637
DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG B...DOSAGE - FILM;BUCCAL - EQ 6.3MG BASE;EQ 1MG BASE
USFDA APPLICATION NUMBER - 205637
DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0...DOSAGE - TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20733
DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2...DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20733
DOSAGE - FILM;BUCCAL - EQ 0.075MG BASE
USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL - EQ 0.15MG BASE
USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL - EQ 0.3MG BASE
USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL - EQ 0.45MG BASE
USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL - EQ 0.6MG BASE
USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL - EQ 0.75MG BASE
USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL - EQ 0.9MG BASE
USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BA...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 12MG BASE;EQ 3MG BASE
USFDA APPLICATION NUMBER - 22410
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE
USFDA APPLICATION NUMBER - 22410
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 4MG BASE;EQ 1MG BASE
USFDA APPLICATION NUMBER - 22410
DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE
USFDA APPLICATION NUMBER - 22410
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REF. STANDARDS & IMPURITIES
EDQM
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ABOUT THIS PAGE
A SUBOXONE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of SUBOXONE, including repackagers and relabelers. The FDA regulates SUBOXONE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. SUBOXONE 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 SUBOXONE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A SUBOXONE supplier is an individual or a company that provides SUBOXONE active pharmaceutical ingredient (API) or SUBOXONE finished formulations upon request. The SUBOXONE suppliers may include SUBOXONE API manufacturers, exporters, distributors and traders.
click here to find a list of SUBOXONE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A SUBOXONE DMF (Drug Master File) is a document detailing the whole manufacturing process of SUBOXONE active pharmaceutical ingredient (API) in detail. Different forms of SUBOXONE DMFs exist exist since differing nations have different regulations, such as SUBOXONE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A SUBOXONE DMF submitted to regulatory agencies in the US is known as a USDMF. SUBOXONE USDMF includes data on SUBOXONE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The SUBOXONE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of SUBOXONE 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 SUBOXONE Drug Master File in Japan (SUBOXONE JDMF) empowers SUBOXONE 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 SUBOXONE JDMF during the approval evaluation for pharmaceutical products. At the time of SUBOXONE 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 SUBOXONE suppliers with JDMF on PharmaCompass.
A SUBOXONE CEP of the European Pharmacopoeia monograph is often referred to as a SUBOXONE Certificate of Suitability (COS). The purpose of a SUBOXONE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of SUBOXONE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of SUBOXONE to their clients by showing that a SUBOXONE CEP has been issued for it. The manufacturer submits a SUBOXONE CEP (COS) as part of the market authorization procedure, and it takes on the role of a SUBOXONE CEP holder for the record. Additionally, the data presented in the SUBOXONE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the SUBOXONE DMF.
A SUBOXONE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. SUBOXONE 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 SUBOXONE suppliers with CEP (COS) on PharmaCompass.
A SUBOXONE written confirmation (SUBOXONE WC) is an official document issued by a regulatory agency to a SUBOXONE manufacturer, verifying that the manufacturing facility of a SUBOXONE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting SUBOXONE APIs or SUBOXONE finished pharmaceutical products to another nation, regulatory agencies frequently require a SUBOXONE WC (written confirmation) as part of the regulatory process.
click here to find a list of SUBOXONE 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 SUBOXONE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for SUBOXONE 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 SUBOXONE 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 SUBOXONE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a SUBOXONE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of SUBOXONE suppliers with NDC on PharmaCompass.
SUBOXONE 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 SUBOXONE 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 SUBOXONE GMP manufacturer or SUBOXONE GMP API supplier for your needs.
A SUBOXONE CoA (Certificate of Analysis) is a formal document that attests to SUBOXONE's compliance with SUBOXONE specifications and serves as a tool for batch-level quality control.
SUBOXONE CoA mostly includes findings from lab analyses of a specific batch. For each SUBOXONE 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.
SUBOXONE may be tested according to a variety of international standards, such as European Pharmacopoeia (SUBOXONE EP), SUBOXONE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (SUBOXONE USP).
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