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KDMF
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VMF
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Australia
DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2019-06-04
Pay. Date : 2016-09-08
DMF Number : 29885
Submission : 2016-08-16
Status :
Type : II
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-23
Pay. Date : 2012-11-23
DMF Number : 23683
Submission : 2010-04-05
Status :
Type : II
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Complete
Rev. Date : 2012-12-26
Pay. Date : 2012-11-30
DMF Number : 19109
Submission : 2006-01-12
Status :
Type : II
Aspen API. More than just an API™
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7099
Submission : 1987-08-06
Status :
Type : II
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : Complete
Rev. Date : 2012-11-30
Pay. Date : 2012-11-13
DMF Number : 16419
Submission : 2003-01-29
Status :
Type : II
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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- INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 Buprenorphine HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Buprenorphine HCl, including repackagers and relabelers. The FDA regulates Buprenorphine HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Buprenorphine HCl 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 Buprenorphine HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Buprenorphine HCl supplier is an individual or a company that provides Buprenorphine HCl active pharmaceutical ingredient (API) or Buprenorphine HCl finished formulations upon request. The Buprenorphine HCl suppliers may include Buprenorphine HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Buprenorphine HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Buprenorphine HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Buprenorphine HCl active pharmaceutical ingredient (API) in detail. Different forms of Buprenorphine HCl DMFs exist exist since differing nations have different regulations, such as Buprenorphine HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Buprenorphine HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Buprenorphine HCl USDMF includes data on Buprenorphine HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Buprenorphine HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Buprenorphine HCl 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 Buprenorphine HCl Drug Master File in Japan (Buprenorphine HCl JDMF) empowers Buprenorphine HCl 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 Buprenorphine HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Buprenorphine HCl 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 Buprenorphine HCl suppliers with JDMF on PharmaCompass.
A Buprenorphine HCl CEP of the European Pharmacopoeia monograph is often referred to as a Buprenorphine HCl Certificate of Suitability (COS). The purpose of a Buprenorphine HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Buprenorphine HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Buprenorphine HCl to their clients by showing that a Buprenorphine HCl CEP has been issued for it. The manufacturer submits a Buprenorphine HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Buprenorphine HCl CEP holder for the record. Additionally, the data presented in the Buprenorphine HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Buprenorphine HCl DMF.
A Buprenorphine HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Buprenorphine HCl 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 Buprenorphine HCl suppliers with CEP (COS) on PharmaCompass.
A Buprenorphine HCl written confirmation (Buprenorphine HCl WC) is an official document issued by a regulatory agency to a Buprenorphine HCl manufacturer, verifying that the manufacturing facility of a Buprenorphine HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Buprenorphine HCl APIs or Buprenorphine HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Buprenorphine HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Buprenorphine HCl 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 Buprenorphine HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Buprenorphine HCl 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 Buprenorphine HCl 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 Buprenorphine HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Buprenorphine HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Buprenorphine HCl suppliers with NDC on PharmaCompass.
Buprenorphine HCl 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 Buprenorphine HCl 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 Buprenorphine HCl GMP manufacturer or Buprenorphine HCl GMP API supplier for your needs.
A Buprenorphine HCl CoA (Certificate of Analysis) is a formal document that attests to Buprenorphine HCl's compliance with Buprenorphine HCl specifications and serves as a tool for batch-level quality control.
Buprenorphine HCl CoA mostly includes findings from lab analyses of a specific batch. For each Buprenorphine HCl 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.
Buprenorphine HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Buprenorphine HCl EP), Buprenorphine HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Buprenorphine HCl USP).
