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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- INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET;SUBLINGUAL - EQ 2MG BASE;EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
A BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, including repackagers and relabelers. The FDA regulates BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 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 HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE supplier is an individual or a company that provides BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE active pharmaceutical ingredient (API) or BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE finished formulations upon request. The BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE suppliers may include BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE API manufacturers, exporters, distributors and traders.
click here to find a list of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DMF (Drug Master File) is a document detailing the whole manufacturing process of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE active pharmaceutical ingredient (API) in detail. Different forms of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DMFs exist exist since differing nations have different regulations, such as BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DMF submitted to regulatory agencies in the US is known as a USDMF. BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE USDMF includes data on BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 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 HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE Drug Master File in Japan (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE JDMF) empowers BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 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 HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE JDMF during the approval evaluation for pharmaceutical products. At the time of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 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 HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE suppliers with JDMF on PharmaCompass.
A BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE CEP of the European Pharmacopoeia monograph is often referred to as a BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE Certificate of Suitability (COS). The purpose of a BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE to their clients by showing that a BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE CEP has been issued for it. The manufacturer submits a BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE CEP (COS) as part of the market authorization procedure, and it takes on the role of a BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE CEP holder for the record. Additionally, the data presented in the BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DMF.
A BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 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 HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE suppliers with CEP (COS) on PharmaCompass.
A BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE written confirmation (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE WC) is an official document issued by a regulatory agency to a BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE manufacturer, verifying that the manufacturing facility of a BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE APIs or BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE finished pharmaceutical products to another nation, regulatory agencies frequently require a BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE WC (written confirmation) as part of the regulatory process.
click here to find a list of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 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 HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 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 HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 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 HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE suppliers with NDC on PharmaCompass.
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 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 HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 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 HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE GMP manufacturer or BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE GMP API supplier for your needs.
A BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE CoA (Certificate of Analysis) is a formal document that attests to BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE's compliance with BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE specifications and serves as a tool for batch-level quality control.
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE CoA mostly includes findings from lab analyses of a specific batch. For each BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE 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 HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE may be tested according to a variety of international standards, such as European Pharmacopoeia (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE EP), BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE JP (Japanese Pharmacopeia) and the US Pharmacopoeia (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE USP).
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