Synopsis
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KDMF
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VMF
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FDA Orange Book
DRUG PRODUCT COMPOSITIONS
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US Patents
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US Exclusivities
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Health Canada Patents
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Data Compilation #PharmaFlow
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Stock Recap #PipelineProspector
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]CEP/COS
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : CEP 1996-016 - Rev 14
Status : Valid
Issue Date : 2024-05-06
Type : Chemical
Substance Number : 1060
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
Certificate Number : R1-CEP 2006-029 - Rev 03
Status : Valid
Issue Date : 2022-06-10
Type : Chemical
Substance Number : 1060
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] JDMF
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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 ...
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
About the Company : LGM Pharma is a global leader in sourcing hard-to-find APIs and intermediates for the pharmaceutical and biotech industries. LGM is also a full service CDMO providing formulation, ...
Farmak works in the development, production and marketing of APIs, Intermediates & Specialties// FDA inspected.
About the Company : Farmak, A.S. is a privately held chemical and pharmaceutical company based in the Czech Republic. It specializes in researching, developing and producing active pharmaceutical ingr...
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...
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API/FDF Prices: Book a Demo to explore the features and consider upgrading later
API Imports and Exports
INTERMEDIATE SUPPLIERS
PMC Isochem is your partner for smart CDMOs of Intermediates, APIs, & excipients & a catalog of Intermediates & Generic APIs.
1-Piperazinecarbonyl chloride, 4-methyl, HCl
CAS Number : 55112-42-0
End Use API : Zopiclone
About The Company : PMC Isochem is a CDMO company acquired by PMC International in 2017. It manufactures cGMP intermediates, active pharmaceutical ingredients and functional excipi...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
CAS Number : 1072-98-6
End Use API : Zopiclone
About The Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API...
Zeon Pharma is a manufacturer and supplier of APIs & Intermediates.
6-(5-CHLOROPYRIDINE-2-YL)5-(4-METHYLPIPERAZINE-1YL...
CAS Number : 43200-82-4
End Use API : Zopiclone
About The Company : Zeon Pharma Industries India Pvt ltd is an ISO & GMP certified manufacturer of Bulk drugs & Intermediate and also supplies our associate manufacturing plant API...
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]FDF Dossiers
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Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Regulatory Info : Originator
Registration Country : South Africa
Brand Name : Imovane
Dosage Form : TAB
Dosage Strength : 400mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Generic
Registration Country : South Africa
Brand Name : Alchera
Dosage Form : TAB
Dosage Strength : 7.5mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Generic
Registration Country : South Africa
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NEWS #PharmaBuzz
Global Sales Information
Regulatory FDF Prices
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class C
Dosage Form :
Dosage Strength : 20 Cpr Riv Div 7.5 Mg
Price Per Pack (Euro) : 9.38
Published in :
Country : Italy
RX/OTC/DISCN : Class C
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5 mg
Price Per Pack (Euro) : 6.853
Published in :
Country : Norway
RX/OTC/DISCN :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5 mg
Price Per Pack (Euro) : 9.559
Published in :
Country : Norway
RX/OTC/DISCN :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 5 mg
Price Per Pack (Euro) : 19.019
Published in :
Country : Norway
RX/OTC/DISCN :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 7.5 mg
Price Per Pack (Euro) : 7.436
Published in :
Country : Norway
RX/OTC/DISCN :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 7.5 mg
Price Per Pack (Euro) : 11.308
Published in :
Country : Norway
RX/OTC/DISCN :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN :
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 7.5 mg
Price Per Pack (Euro) : 24.86
Published in :
Country : Norway
RX/OTC/DISCN :
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class B
Dosage Form : Film-Coated Tablets
Dosage Strength : 7.5mg
Price Per Pack (Euro) : 6.17
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class B
Dosage Form : Film-Coated Tablets
Dosage Strength : 7.5mg
Price Per Pack (Euro) : 20.57
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
RX/OTC/DISCN : Class B
Dosage Form : Film-Coated Tablets
Dosage Strength : 7.5mg
Price Per Pack (Euro) : 2.98
Published in :
Country : Switzerland
RX/OTC/DISCN : Class B
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results]Market Place
REF. STANDARDS & IMPURITIES
ANALYTICAL
ABOUT THIS PAGE
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PharmaCompass offers a list of Zopiclone 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 Zopiclone manufacturer or Zopiclone supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Zopiclone manufacturer or Zopiclone supplier.
PharmaCompass also assists you with knowing the Zopiclone API Price utilized in the formulation of products. Zopiclone API Price is not always fixed or binding as the Zopiclone Price is obtained through a variety of data sources. The Zopiclone Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A zopiclodura manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of zopiclodura, including repackagers and relabelers. The FDA regulates zopiclodura manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. zopiclodura 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 zopiclodura manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A zopiclodura supplier is an individual or a company that provides zopiclodura active pharmaceutical ingredient (API) or zopiclodura finished formulations upon request. The zopiclodura suppliers may include zopiclodura API manufacturers, exporters, distributors and traders.
click here to find a list of zopiclodura suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A zopiclodura DMF (Drug Master File) is a document detailing the whole manufacturing process of zopiclodura active pharmaceutical ingredient (API) in detail. Different forms of zopiclodura DMFs exist exist since differing nations have different regulations, such as zopiclodura USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A zopiclodura DMF submitted to regulatory agencies in the US is known as a USDMF. zopiclodura USDMF includes data on zopiclodura's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The zopiclodura USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of zopiclodura 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 zopiclodura Drug Master File in Japan (zopiclodura JDMF) empowers zopiclodura 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 zopiclodura JDMF during the approval evaluation for pharmaceutical products. At the time of zopiclodura 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 zopiclodura suppliers with JDMF on PharmaCompass.
A zopiclodura CEP of the European Pharmacopoeia monograph is often referred to as a zopiclodura Certificate of Suitability (COS). The purpose of a zopiclodura CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of zopiclodura EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of zopiclodura to their clients by showing that a zopiclodura CEP has been issued for it. The manufacturer submits a zopiclodura CEP (COS) as part of the market authorization procedure, and it takes on the role of a zopiclodura CEP holder for the record. Additionally, the data presented in the zopiclodura CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the zopiclodura DMF.
A zopiclodura CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. zopiclodura 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 zopiclodura suppliers with CEP (COS) on PharmaCompass.
A zopiclodura written confirmation (zopiclodura WC) is an official document issued by a regulatory agency to a zopiclodura manufacturer, verifying that the manufacturing facility of a zopiclodura active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting zopiclodura APIs or zopiclodura finished pharmaceutical products to another nation, regulatory agencies frequently require a zopiclodura WC (written confirmation) as part of the regulatory process.
click here to find a list of zopiclodura 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 zopiclodura as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for zopiclodura 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 zopiclodura 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 zopiclodura and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a zopiclodura NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of zopiclodura suppliers with NDC on PharmaCompass.
zopiclodura 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 zopiclodura 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 zopiclodura GMP manufacturer or zopiclodura GMP API supplier for your needs.
A zopiclodura CoA (Certificate of Analysis) is a formal document that attests to zopiclodura's compliance with zopiclodura specifications and serves as a tool for batch-level quality control.
zopiclodura CoA mostly includes findings from lab analyses of a specific batch. For each zopiclodura 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.
zopiclodura may be tested according to a variety of international standards, such as European Pharmacopoeia (zopiclodura EP), zopiclodura JP (Japanese Pharmacopeia) and the US Pharmacopoeia (zopiclodura USP).
