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DRUG PRODUCT COMPOSITIONS
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API SUPPLIERS
Minakem is manufacturing small molecules APIs including corticosteroids
Tenatra connects Indian manufacturers with global buyers through active partners in Germany, Switzerland, Belgium, Spain & Turkey.
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USDMF
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API Imports and Exports
Drugs in Development
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EUROAPI
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Film Formers & Plasticizers
Lubricants & Glidants
Direct Compression
Coating Systems & Additives
Parenteral
Taste Masking
Co-Processed Excipients
Granulation
Topical
Thickeners and Stabilizers
Controlled & Modified Release
Emulsifying Agents
Solubilizers
Chewable & Orodispersible Aids
Soft Gelatin
Disintegrants & Superdisintegrants
API Stability Enhancers
Digital Content
DATA COMPILATION #PharmaFlow
NEWS #PharmaBuzz
Global Sales Information
US Medicaid Prescriptions
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APIs
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REF. STANDARDS & IMPURITIES
ABOUT THIS PAGE
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PharmaCompass offers a list of Pyridostigmine 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 Pyridostigmine manufacturer or Pyridostigmine supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Pyridostigmine manufacturer or Pyridostigmine supplier.
PharmaCompass also assists you with knowing the Pyridostigmine API Price utilized in the formulation of products. Pyridostigmine API Price is not always fixed or binding as the Pyridostigmine Price is obtained through a variety of data sources. The Pyridostigmine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Kalimin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Kalimin, including repackagers and relabelers. The FDA regulates Kalimin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Kalimin 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 Kalimin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Kalimin supplier is an individual or a company that provides Kalimin active pharmaceutical ingredient (API) or Kalimin finished formulations upon request. The Kalimin suppliers may include Kalimin API manufacturers, exporters, distributors and traders.
click here to find a list of Kalimin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Kalimin DMF (Drug Master File) is a document detailing the whole manufacturing process of Kalimin active pharmaceutical ingredient (API) in detail. Different forms of Kalimin DMFs exist exist since differing nations have different regulations, such as Kalimin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Kalimin DMF submitted to regulatory agencies in the US is known as a USDMF. Kalimin USDMF includes data on Kalimin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Kalimin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Kalimin 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 Kalimin Drug Master File in Japan (Kalimin JDMF) empowers Kalimin 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 Kalimin JDMF during the approval evaluation for pharmaceutical products. At the time of Kalimin 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 Kalimin suppliers with JDMF on PharmaCompass.
In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.
Pharmaceutical companies submit a Kalimin Drug Master File in Korea (Kalimin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Kalimin. The MFDS reviews the Kalimin KDMF as part of the drug registration process and uses the information provided in the Kalimin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Kalimin KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Kalimin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Kalimin suppliers with KDMF on PharmaCompass.
A Kalimin CEP of the European Pharmacopoeia monograph is often referred to as a Kalimin Certificate of Suitability (COS). The purpose of a Kalimin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Kalimin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Kalimin to their clients by showing that a Kalimin CEP has been issued for it. The manufacturer submits a Kalimin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Kalimin CEP holder for the record. Additionally, the data presented in the Kalimin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Kalimin DMF.
A Kalimin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Kalimin 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 Kalimin suppliers with CEP (COS) on PharmaCompass.
A Kalimin written confirmation (Kalimin WC) is an official document issued by a regulatory agency to a Kalimin manufacturer, verifying that the manufacturing facility of a Kalimin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Kalimin APIs or Kalimin finished pharmaceutical products to another nation, regulatory agencies frequently require a Kalimin WC (written confirmation) as part of the regulatory process.
click here to find a list of Kalimin 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 Kalimin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Kalimin 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 Kalimin 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 Kalimin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Kalimin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Kalimin suppliers with NDC on PharmaCompass.
Kalimin 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 Kalimin 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 Kalimin GMP manufacturer or Kalimin GMP API supplier for your needs.
A Kalimin CoA (Certificate of Analysis) is a formal document that attests to Kalimin's compliance with Kalimin specifications and serves as a tool for batch-level quality control.
Kalimin CoA mostly includes findings from lab analyses of a specific batch. For each Kalimin 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.
Kalimin may be tested according to a variety of international standards, such as European Pharmacopoeia (Kalimin EP), Kalimin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Kalimin USP).
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