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API SUPPLIERS
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.
Jai Radhe Sales is your partner for all your sourcing needs.
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
Atman Pharma Private Limited: A One Stop Solution Provider to All Your API Needs.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
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USDMF
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 6425
Submission : 1986-06-11
Status :
Type : II
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3926
Submission : 1980-07-31
Status :
Type : II
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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 ...
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...
Atman Pharma Private Limited: A One Stop Solution Provider to All Your API Needs.
About the Company : Atman Pharma Private Limited is a fully integrated pharmaceutical company that has distinguished itself as a leader in Bulk Drugs (API) marketing both domestically in India and ove...
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ABOUT THIS PAGE
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PharmaCompass offers a list of Chloroquine Phosphate 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 Chloroquine Phosphate manufacturer or Chloroquine Phosphate supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Chloroquine Phosphate manufacturer or Chloroquine Phosphate supplier.
PharmaCompass also assists you with knowing the Chloroquine Phosphate API Price utilized in the formulation of products. Chloroquine Phosphate API Price is not always fixed or binding as the Chloroquine Phosphate Price is obtained through a variety of data sources. The Chloroquine Phosphate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Tanakene manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tanakene, including repackagers and relabelers. The FDA regulates Tanakene manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tanakene 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 Tanakene manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tanakene supplier is an individual or a company that provides Tanakene active pharmaceutical ingredient (API) or Tanakene finished formulations upon request. The Tanakene suppliers may include Tanakene API manufacturers, exporters, distributors and traders.
click here to find a list of Tanakene suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Tanakene DMF (Drug Master File) is a document detailing the whole manufacturing process of Tanakene active pharmaceutical ingredient (API) in detail. Different forms of Tanakene DMFs exist exist since differing nations have different regulations, such as Tanakene USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Tanakene DMF submitted to regulatory agencies in the US is known as a USDMF. Tanakene USDMF includes data on Tanakene's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Tanakene USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Tanakene suppliers with USDMF on PharmaCompass.
A Tanakene CEP of the European Pharmacopoeia monograph is often referred to as a Tanakene Certificate of Suitability (COS). The purpose of a Tanakene CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Tanakene EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Tanakene to their clients by showing that a Tanakene CEP has been issued for it. The manufacturer submits a Tanakene CEP (COS) as part of the market authorization procedure, and it takes on the role of a Tanakene CEP holder for the record. Additionally, the data presented in the Tanakene CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Tanakene DMF.
A Tanakene CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Tanakene 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 Tanakene suppliers with CEP (COS) on PharmaCompass.
A Tanakene written confirmation (Tanakene WC) is an official document issued by a regulatory agency to a Tanakene manufacturer, verifying that the manufacturing facility of a Tanakene active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Tanakene APIs or Tanakene finished pharmaceutical products to another nation, regulatory agencies frequently require a Tanakene WC (written confirmation) as part of the regulatory process.
click here to find a list of Tanakene 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 Tanakene as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Tanakene 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 Tanakene 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 Tanakene and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Tanakene NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Tanakene suppliers with NDC on PharmaCompass.
Tanakene 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 Tanakene 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 Tanakene GMP manufacturer or Tanakene GMP API supplier for your needs.
A Tanakene CoA (Certificate of Analysis) is a formal document that attests to Tanakene's compliance with Tanakene specifications and serves as a tool for batch-level quality control.
Tanakene CoA mostly includes findings from lab analyses of a specific batch. For each Tanakene 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.
Tanakene may be tested according to a variety of international standards, such as European Pharmacopoeia (Tanakene EP), Tanakene JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Tanakene USP).
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