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