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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
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Jai Radhe Sales is your partner for all your sourcing needs.
Harika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.
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Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.
About the Company : Biophore, founded in 2007, has established itself as a reliable partner in the development and manufacturing of niche and complex pharmaceutical products. With 4 USFDA and EU-appro...
Jai Radhe Sales is your partner for all your sourcing needs.
About the Company : Jai Radhe Sales was founded in 1999 as an out-of-the-box distribution firm specializing in the global supply of high-quality pharmaceutical ingredients. The firm provides complete ...
Harika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.
About the Company : Our endeavours also lie in the import, and domestic sourcing of raw materials from reliable vendors of the market. We have an excellent infrastructure with world class cGMP facilit...
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PharmaCompass offers a list of Prochlorperazine Maleate 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 Prochlorperazine Maleate manufacturer or Prochlorperazine Maleate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Prochlorperazine Maleate manufacturer or Prochlorperazine Maleate supplier.
PharmaCompass also assists you with knowing the Prochlorperazine Maleate API Price utilized in the formulation of products. Prochlorperazine Maleate API Price is not always fixed or binding as the Prochlorperazine Maleate Price is obtained through a variety of data sources. The Prochlorperazine Maleate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Prochlorperazine Maleate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Prochlorperazine Maleate, including repackagers and relabelers. The FDA regulates Prochlorperazine Maleate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Prochlorperazine Maleate 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 Prochlorperazine Maleate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Prochlorperazine Maleate supplier is an individual or a company that provides Prochlorperazine Maleate active pharmaceutical ingredient (API) or Prochlorperazine Maleate finished formulations upon request. The Prochlorperazine Maleate suppliers may include Prochlorperazine Maleate API manufacturers, exporters, distributors and traders.
click here to find a list of Prochlorperazine Maleate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Prochlorperazine Maleate DMF (Drug Master File) is a document detailing the whole manufacturing process of Prochlorperazine Maleate active pharmaceutical ingredient (API) in detail. Different forms of Prochlorperazine Maleate DMFs exist exist since differing nations have different regulations, such as Prochlorperazine Maleate USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Prochlorperazine Maleate DMF submitted to regulatory agencies in the US is known as a USDMF. Prochlorperazine Maleate USDMF includes data on Prochlorperazine Maleate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Prochlorperazine Maleate USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Prochlorperazine Maleate 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 Prochlorperazine Maleate Drug Master File in Japan (Prochlorperazine Maleate JDMF) empowers Prochlorperazine Maleate 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 Prochlorperazine Maleate JDMF during the approval evaluation for pharmaceutical products. At the time of Prochlorperazine Maleate 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 Prochlorperazine Maleate suppliers with JDMF on PharmaCompass.
A Prochlorperazine Maleate CEP of the European Pharmacopoeia monograph is often referred to as a Prochlorperazine Maleate Certificate of Suitability (COS). The purpose of a Prochlorperazine Maleate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Prochlorperazine Maleate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Prochlorperazine Maleate to their clients by showing that a Prochlorperazine Maleate CEP has been issued for it. The manufacturer submits a Prochlorperazine Maleate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Prochlorperazine Maleate CEP holder for the record. Additionally, the data presented in the Prochlorperazine Maleate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Prochlorperazine Maleate DMF.
A Prochlorperazine Maleate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Prochlorperazine Maleate 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 Prochlorperazine Maleate suppliers with CEP (COS) on PharmaCompass.
A Prochlorperazine Maleate written confirmation (Prochlorperazine Maleate WC) is an official document issued by a regulatory agency to a Prochlorperazine Maleate manufacturer, verifying that the manufacturing facility of a Prochlorperazine Maleate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Prochlorperazine Maleate APIs or Prochlorperazine Maleate finished pharmaceutical products to another nation, regulatory agencies frequently require a Prochlorperazine Maleate WC (written confirmation) as part of the regulatory process.
click here to find a list of Prochlorperazine Maleate 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 Prochlorperazine Maleate as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Prochlorperazine Maleate 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 Prochlorperazine Maleate 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 Prochlorperazine Maleate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Prochlorperazine Maleate NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Prochlorperazine Maleate suppliers with NDC on PharmaCompass.
Prochlorperazine Maleate 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 Prochlorperazine Maleate 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 Prochlorperazine Maleate GMP manufacturer or Prochlorperazine Maleate GMP API supplier for your needs.
A Prochlorperazine Maleate CoA (Certificate of Analysis) is a formal document that attests to Prochlorperazine Maleate's compliance with Prochlorperazine Maleate specifications and serves as a tool for batch-level quality control.
Prochlorperazine Maleate CoA mostly includes findings from lab analyses of a specific batch. For each Prochlorperazine Maleate 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.
Prochlorperazine Maleate may be tested according to a variety of international standards, such as European Pharmacopoeia (Prochlorperazine Maleate EP), Prochlorperazine Maleate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Prochlorperazine Maleate USP).
