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