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Australia
DRUG PRODUCT COMPOSITIONS0
FDF
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Data Compilation #PharmaFlow
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Weekly News Recap #Phispers
API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - EQ 0.25MG BASE **Feder...DOSAGE - TABLET;ORAL - EQ 0.25MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20658
DOSAGE - TABLET;ORAL - EQ 0.5MG BASE **Federa...DOSAGE - TABLET;ORAL - EQ 0.5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20658
DOSAGE - TABLET;ORAL - EQ 1MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 1MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20658
DOSAGE - TABLET;ORAL - EQ 2MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20658
DOSAGE - TABLET;ORAL - EQ 3MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20658
DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20658
DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal ...DOSAGE - TABLET;ORAL - EQ 5MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 20658
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 1...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 12MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22008
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22008
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 3...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 3MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22008
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 4...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 4MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22008
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 6...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 6MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22008
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 8...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 8MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 22008
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ropinirole 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 Ropinirole Hydrochloride manufacturer or Ropinirole Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ropinirole Hydrochloride manufacturer or Ropinirole Hydrochloride supplier.
PharmaCompass also assists you with knowing the Ropinirole Hydrochloride API Price utilized in the formulation of products. Ropinirole Hydrochloride API Price is not always fixed or binding as the Ropinirole Hydrochloride Price is obtained through a variety of data sources. The Ropinirole Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Ropinirole HCl manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ropinirole HCl, including repackagers and relabelers. The FDA regulates Ropinirole HCl manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ropinirole 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 Ropinirole HCl manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ropinirole HCl supplier is an individual or a company that provides Ropinirole HCl active pharmaceutical ingredient (API) or Ropinirole HCl finished formulations upon request. The Ropinirole HCl suppliers may include Ropinirole HCl API manufacturers, exporters, distributors and traders.
click here to find a list of Ropinirole HCl suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ropinirole HCl DMF (Drug Master File) is a document detailing the whole manufacturing process of Ropinirole HCl active pharmaceutical ingredient (API) in detail. Different forms of Ropinirole HCl DMFs exist exist since differing nations have different regulations, such as Ropinirole HCl USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ropinirole HCl DMF submitted to regulatory agencies in the US is known as a USDMF. Ropinirole HCl USDMF includes data on Ropinirole HCl's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ropinirole HCl USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ropinirole 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 Ropinirole HCl Drug Master File in Japan (Ropinirole HCl JDMF) empowers Ropinirole 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 Ropinirole HCl JDMF during the approval evaluation for pharmaceutical products. At the time of Ropinirole 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 Ropinirole HCl suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Ropinirole HCl Drug Master File in Korea (Ropinirole HCl KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ropinirole HCl. The MFDS reviews the Ropinirole HCl KDMF as part of the drug registration process and uses the information provided in the Ropinirole HCl KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ropinirole HCl KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Ropinirole HCl API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ropinirole HCl suppliers with KDMF on PharmaCompass.
A Ropinirole HCl CEP of the European Pharmacopoeia monograph is often referred to as a Ropinirole HCl Certificate of Suitability (COS). The purpose of a Ropinirole HCl CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ropinirole HCl EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ropinirole HCl to their clients by showing that a Ropinirole HCl CEP has been issued for it. The manufacturer submits a Ropinirole HCl CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ropinirole HCl CEP holder for the record. Additionally, the data presented in the Ropinirole HCl CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ropinirole HCl DMF.
A Ropinirole HCl CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ropinirole 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 Ropinirole HCl suppliers with CEP (COS) on PharmaCompass.
A Ropinirole HCl written confirmation (Ropinirole HCl WC) is an official document issued by a regulatory agency to a Ropinirole HCl manufacturer, verifying that the manufacturing facility of a Ropinirole HCl active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Ropinirole HCl APIs or Ropinirole HCl finished pharmaceutical products to another nation, regulatory agencies frequently require a Ropinirole HCl WC (written confirmation) as part of the regulatory process.
click here to find a list of Ropinirole 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 Ropinirole HCl as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ropinirole 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 Ropinirole 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 Ropinirole HCl and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ropinirole HCl NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ropinirole HCl suppliers with NDC on PharmaCompass.
Ropinirole 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 Ropinirole 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 Ropinirole HCl GMP manufacturer or Ropinirole HCl GMP API supplier for your needs.
A Ropinirole HCl CoA (Certificate of Analysis) is a formal document that attests to Ropinirole HCl's compliance with Ropinirole HCl specifications and serves as a tool for batch-level quality control.
Ropinirole HCl CoA mostly includes findings from lab analyses of a specific batch. For each Ropinirole 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.
Ropinirole HCl may be tested according to a variety of international standards, such as European Pharmacopoeia (Ropinirole HCl EP), Ropinirole HCl JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ropinirole HCl USP).
