Synopsis
0
KDMF
0
VMF
0
Australia
DRUG PRODUCT COMPOSITIONS0
Stock Recap #PipelineProspector
0
Weekly News Recap #Phispers
API SUPPLIERS
Veranova: A CDMO that manages complexity with confidence.
Click Us!
JDMF
NDC
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.
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]
USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] EU WC
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NDC API
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Listed Suppliers
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
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDA Orange Book
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Europe
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Canada
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
Related Excipient Companies
Minakem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Rochem International Inc
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]SPI Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharm-RX Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Faran Shimi Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Boai NKY Pharmaceuticals Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Chynops Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nanjing Well Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pfanstiehl
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pramukh Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zeal MediPharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]ACG Worldwide
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Actylis
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Alcedo Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Anhui Sunhere Pharmaceutical Excipients Co.,Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ashland
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Bioplus Life Sciences
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Corel Pharma Chem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]DFE Pharma
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Finar
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Gangwal Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ideal Cures Pvt Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ingredion Pharma Solutions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kerry
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Kima Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lonza Capsugel
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Lubrizol Life Science Health
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Microlex e.U
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]NEWEDGE Overseas
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nippon Fine Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Nomisma Healthcare
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Novo Excipients
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pharmatrans-Sanaq
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Pluviaendo
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Prachin Chemical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qianhao Chemical (Hebei) Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Qualicaps
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Roquette
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Seppic
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Shenmei Pharmaceutical Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shanghai Welltone Material Technology Co., Ltd
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Shijiazhuang Huaxu Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Sigachi Industries
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Silverline Chemicals
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Symrise
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]The Dow Chemical Company
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Ulanqab Kema New Material
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Valens Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Vasa Pharmachem
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Zhejiang Huakang Pharmaceutical
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Fillers, Diluents & Binders
Coating Systems & Additives
Thickeners and Stabilizers
Disintegrants & Superdisintegrants
Direct Compression
Controlled & Modified Release
Taste Masking
Granulation
Solubilizers
Chewable & Orodispersible Aids
Co-Processed Excipients
Lubricants & Glidants
Topical
Film Formers & Plasticizers
Parenteral
Rheology Modifiers
Emulsifying Agents
Empty Capsules
API Stability Enhancers
Vegetarian Capsules
Coloring Agents
Surfactant & Foaming Agents
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
88
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 BUNAVAIL manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BUNAVAIL, including repackagers and relabelers. The FDA regulates BUNAVAIL manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BUNAVAIL 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 BUNAVAIL manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A BUNAVAIL supplier is an individual or a company that provides BUNAVAIL active pharmaceutical ingredient (API) or BUNAVAIL finished formulations upon request. The BUNAVAIL suppliers may include BUNAVAIL API manufacturers, exporters, distributors and traders.
click here to find a list of BUNAVAIL suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A BUNAVAIL DMF (Drug Master File) is a document detailing the whole manufacturing process of BUNAVAIL active pharmaceutical ingredient (API) in detail. Different forms of BUNAVAIL DMFs exist exist since differing nations have different regulations, such as BUNAVAIL USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BUNAVAIL DMF submitted to regulatory agencies in the US is known as a USDMF. BUNAVAIL USDMF includes data on BUNAVAIL's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BUNAVAIL USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of BUNAVAIL 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 BUNAVAIL Drug Master File in Japan (BUNAVAIL JDMF) empowers BUNAVAIL 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 BUNAVAIL JDMF during the approval evaluation for pharmaceutical products. At the time of BUNAVAIL 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 BUNAVAIL suppliers with JDMF on PharmaCompass.
A BUNAVAIL CEP of the European Pharmacopoeia monograph is often referred to as a BUNAVAIL Certificate of Suitability (COS). The purpose of a BUNAVAIL CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of BUNAVAIL EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of BUNAVAIL to their clients by showing that a BUNAVAIL CEP has been issued for it. The manufacturer submits a BUNAVAIL CEP (COS) as part of the market authorization procedure, and it takes on the role of a BUNAVAIL CEP holder for the record. Additionally, the data presented in the BUNAVAIL CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the BUNAVAIL DMF.
A BUNAVAIL CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. BUNAVAIL 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 BUNAVAIL suppliers with CEP (COS) on PharmaCompass.
A BUNAVAIL written confirmation (BUNAVAIL WC) is an official document issued by a regulatory agency to a BUNAVAIL manufacturer, verifying that the manufacturing facility of a BUNAVAIL active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting BUNAVAIL APIs or BUNAVAIL finished pharmaceutical products to another nation, regulatory agencies frequently require a BUNAVAIL WC (written confirmation) as part of the regulatory process.
click here to find a list of BUNAVAIL 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 BUNAVAIL as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for BUNAVAIL 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 BUNAVAIL 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 BUNAVAIL and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BUNAVAIL NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of BUNAVAIL suppliers with NDC on PharmaCompass.
BUNAVAIL 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 BUNAVAIL 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 BUNAVAIL GMP manufacturer or BUNAVAIL GMP API supplier for your needs.
A BUNAVAIL CoA (Certificate of Analysis) is a formal document that attests to BUNAVAIL's compliance with BUNAVAIL specifications and serves as a tool for batch-level quality control.
BUNAVAIL CoA mostly includes findings from lab analyses of a specific batch. For each BUNAVAIL 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.
BUNAVAIL may be tested according to a variety of international standards, such as European Pharmacopoeia (BUNAVAIL EP), BUNAVAIL JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BUNAVAIL USP).
