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API SUPPLIERS
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Harika Drugs has been providing a qualitative range of Bulk Drugs/ APIs since 1993.
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USDMF
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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, ...
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 ...
Pharm-Rx is a reputed global importer and distributor of pharmaceutical active ingredients.
About the Company : Pharm-Rx has earned an outstanding reputation since its establishment in 1991, serving as a reputable importer and distributor of active ingredients to the pharmaceutical, nutritio...
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...
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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API Imports and Exports
Drugs in Development
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DOSAGE - TABLET;ORAL - 12.5MG
USFDA APPLICATION NUMBER - 10721
DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 10721
DOSAGE - TABLET;ORAL - 50MG
USFDA APPLICATION NUMBER - 10721
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Meclizine 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 Meclizine Hydrochloride manufacturer or Meclizine Hydrochloride supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Meclizine Hydrochloride manufacturer or Meclizine Hydrochloride supplier.
PharmaCompass also assists you with knowing the Meclizine Hydrochloride API Price utilized in the formulation of products. Meclizine Hydrochloride API Price is not always fixed or binding as the Meclizine Hydrochloride Price is obtained through a variety of data sources. The Meclizine Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Agyrax manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Agyrax, including repackagers and relabelers. The FDA regulates Agyrax manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Agyrax 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 Agyrax manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Agyrax supplier is an individual or a company that provides Agyrax active pharmaceutical ingredient (API) or Agyrax finished formulations upon request. The Agyrax suppliers may include Agyrax API manufacturers, exporters, distributors and traders.
click here to find a list of Agyrax suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Agyrax DMF (Drug Master File) is a document detailing the whole manufacturing process of Agyrax active pharmaceutical ingredient (API) in detail. Different forms of Agyrax DMFs exist exist since differing nations have different regulations, such as Agyrax USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Agyrax DMF submitted to regulatory agencies in the US is known as a USDMF. Agyrax USDMF includes data on Agyrax's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Agyrax USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Agyrax suppliers with USDMF on PharmaCompass.
A Agyrax CEP of the European Pharmacopoeia monograph is often referred to as a Agyrax Certificate of Suitability (COS). The purpose of a Agyrax CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Agyrax EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Agyrax to their clients by showing that a Agyrax CEP has been issued for it. The manufacturer submits a Agyrax CEP (COS) as part of the market authorization procedure, and it takes on the role of a Agyrax CEP holder for the record. Additionally, the data presented in the Agyrax CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Agyrax DMF.
A Agyrax CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Agyrax 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 Agyrax suppliers with CEP (COS) on PharmaCompass.
A Agyrax written confirmation (Agyrax WC) is an official document issued by a regulatory agency to a Agyrax manufacturer, verifying that the manufacturing facility of a Agyrax active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Agyrax APIs or Agyrax finished pharmaceutical products to another nation, regulatory agencies frequently require a Agyrax WC (written confirmation) as part of the regulatory process.
click here to find a list of Agyrax 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 Agyrax as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Agyrax 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 Agyrax 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 Agyrax and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Agyrax NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Agyrax suppliers with NDC on PharmaCompass.
Agyrax 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 Agyrax 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 Agyrax GMP manufacturer or Agyrax GMP API supplier for your needs.
A Agyrax CoA (Certificate of Analysis) is a formal document that attests to Agyrax's compliance with Agyrax specifications and serves as a tool for batch-level quality control.
Agyrax CoA mostly includes findings from lab analyses of a specific batch. For each Agyrax 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.
Agyrax may be tested according to a variety of international standards, such as European Pharmacopoeia (Agyrax EP), Agyrax JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Agyrax USP).
