Synopsis
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EU WC
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KDMF
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Europe
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Australia
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South Africa
DRUG PRODUCT COMPOSITIONS
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US Patents
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Health Canada Patents
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FDF
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Data Compilation #PharmaFlow
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API SUPPLIERS
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USDMF
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 24323
Submission : 2010-10-28
Status :
Type : II
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Listed Suppliers
ChemWerth works in generic API development & supply, non-infringement patent strategy development and regulatory support.
About the Company : Established in 1982, ChemWerth is a US-headquartered full-service generic active pharmaceutical ingredient (API) development and supply company. ChemWerth offers cGMP-quality APIs ...
TAPI, a leading global supplier of APIs, provides over 350 products and customized CDMO solutions for every stage of development.
About the Company : Founded in 1935, TAPI Technology & API Services has a long-standing tradition of advancing health through innovation and dedication. Today, we proudly build upon this legacy, drivi...
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Pergolide Mesylate 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 Pergolide Mesylate manufacturer or Pergolide Mesylate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pergolide Mesylate manufacturer or Pergolide Mesylate supplier.
PharmaCompass also assists you with knowing the Pergolide Mesylate API Price utilized in the formulation of products. Pergolide Mesylate API Price is not always fixed or binding as the Pergolide Mesylate Price is obtained through a variety of data sources. The Pergolide Mesylate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Nopar manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nopar, including repackagers and relabelers. The FDA regulates Nopar manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nopar 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 Nopar manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Nopar supplier is an individual or a company that provides Nopar active pharmaceutical ingredient (API) or Nopar finished formulations upon request. The Nopar suppliers may include Nopar API manufacturers, exporters, distributors and traders.
click here to find a list of Nopar suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Nopar DMF (Drug Master File) is a document detailing the whole manufacturing process of Nopar active pharmaceutical ingredient (API) in detail. Different forms of Nopar DMFs exist exist since differing nations have different regulations, such as Nopar USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Nopar DMF submitted to regulatory agencies in the US is known as a USDMF. Nopar USDMF includes data on Nopar's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nopar USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Nopar 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 Nopar Drug Master File in Japan (Nopar JDMF) empowers Nopar 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 Nopar JDMF during the approval evaluation for pharmaceutical products. At the time of Nopar 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 Nopar suppliers with JDMF on PharmaCompass.
A Nopar CEP of the European Pharmacopoeia monograph is often referred to as a Nopar Certificate of Suitability (COS). The purpose of a Nopar CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nopar EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nopar to their clients by showing that a Nopar CEP has been issued for it. The manufacturer submits a Nopar CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nopar CEP holder for the record. Additionally, the data presented in the Nopar CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nopar DMF.
A Nopar CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nopar 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 Nopar suppliers with CEP (COS) 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 Nopar as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Nopar 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 Nopar 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 Nopar and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nopar NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Nopar suppliers with NDC on PharmaCompass.
Nopar 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 Nopar 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 Nopar GMP manufacturer or Nopar GMP API supplier for your needs.
A Nopar CoA (Certificate of Analysis) is a formal document that attests to Nopar's compliance with Nopar specifications and serves as a tool for batch-level quality control.
Nopar CoA mostly includes findings from lab analyses of a specific batch. For each Nopar 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.
Nopar may be tested according to a variety of international standards, such as European Pharmacopoeia (Nopar EP), Nopar JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nopar USP).
