Synopsis
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KDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
Veranova: A CDMO that manages complexity with confidence.
ROW 
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
CEP/COS
NDC
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
Temad- We think of world-class quality.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Aspen API. More than just an API™
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
EU-WC
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USDMF
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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...
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 focused on reinventing active ingredient solutions to meet the needs of customers and patients worldwide sustainably. We are a leading player in APIs with approximately ...
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...
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
About the Company : Tenatra International was established as a proprietorship firm in 1999. It got off to a very good start, supporting clients in the United States, Mexico and Europe. As business opp...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
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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Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : Norway
Brand Name : Espranor
Dosage Form : Lyofilisattablett
Dosage Strength : 8 mg
Packaging : Endose blister pack 7 1item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Ethypharm is an international Pharma company with European roots manufacturing and commercializing essential drugs all over the world.
Regulatory Info :
Registration Country : Norway
Brand Name : Espranor
Dosage Form : Lyofilisattablett
Dosage Strength : 2 mg
Packaging : Endose blister pack 7 1item
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
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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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ABOUT THIS PAGE
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PharmaCompass offers a list of Buprenorphine 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 Buprenorphine Hydrochloride manufacturer or Buprenorphine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Buprenorphine Hydrochloride manufacturer or Buprenorphine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Buprenorphine Hydrochloride API Price utilized in the formulation of products. Buprenorphine Hydrochloride API Price is not always fixed or binding as the Buprenorphine Hydrochloride Price is obtained through a variety of data sources. The Buprenorphine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A BELBUCA manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BELBUCA, including repackagers and relabelers. The FDA regulates BELBUCA manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BELBUCA 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 BELBUCA manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A BELBUCA supplier is an individual or a company that provides BELBUCA active pharmaceutical ingredient (API) or BELBUCA finished formulations upon request. The BELBUCA suppliers may include BELBUCA API manufacturers, exporters, distributors and traders.
click here to find a list of BELBUCA suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A BELBUCA DMF (Drug Master File) is a document detailing the whole manufacturing process of BELBUCA active pharmaceutical ingredient (API) in detail. Different forms of BELBUCA DMFs exist exist since differing nations have different regulations, such as BELBUCA USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BELBUCA DMF submitted to regulatory agencies in the US is known as a USDMF. BELBUCA USDMF includes data on BELBUCA's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BELBUCA USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of BELBUCA 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 BELBUCA Drug Master File in Japan (BELBUCA JDMF) empowers BELBUCA 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 BELBUCA JDMF during the approval evaluation for pharmaceutical products. At the time of BELBUCA 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 BELBUCA suppliers with JDMF on PharmaCompass.
A BELBUCA CEP of the European Pharmacopoeia monograph is often referred to as a BELBUCA Certificate of Suitability (COS). The purpose of a BELBUCA CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of BELBUCA EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of BELBUCA to their clients by showing that a BELBUCA CEP has been issued for it. The manufacturer submits a BELBUCA CEP (COS) as part of the market authorization procedure, and it takes on the role of a BELBUCA CEP holder for the record. Additionally, the data presented in the BELBUCA CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the BELBUCA DMF.
A BELBUCA CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. BELBUCA 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 BELBUCA suppliers with CEP (COS) on PharmaCompass.
A BELBUCA written confirmation (BELBUCA WC) is an official document issued by a regulatory agency to a BELBUCA manufacturer, verifying that the manufacturing facility of a BELBUCA active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting BELBUCA APIs or BELBUCA finished pharmaceutical products to another nation, regulatory agencies frequently require a BELBUCA WC (written confirmation) as part of the regulatory process.
click here to find a list of BELBUCA 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 BELBUCA as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for BELBUCA 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 BELBUCA 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 BELBUCA and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BELBUCA NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of BELBUCA suppliers with NDC on PharmaCompass.
BELBUCA 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 BELBUCA 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 BELBUCA GMP manufacturer or BELBUCA GMP API supplier for your needs.
A BELBUCA CoA (Certificate of Analysis) is a formal document that attests to BELBUCA's compliance with BELBUCA specifications and serves as a tool for batch-level quality control.
BELBUCA CoA mostly includes findings from lab analyses of a specific batch. For each BELBUCA 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.
BELBUCA may be tested according to a variety of international standards, such as European Pharmacopoeia (BELBUCA EP), BELBUCA JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BELBUCA USP).
