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DOSAGE - LOTION;TOPICAL - 0.5%
USFDA APPLICATION NUMBER - 202736
DOSAGE - CREAM;TOPICAL - 1%
USFDA APPLICATION NUMBER - 206255
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EUROAPI
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ABOUT THIS PAGE
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PharmaCompass offers a list of Ivermectin 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 Ivermectin manufacturer or Ivermectin supplier for your needs.
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PharmaCompass also assists you with knowing the Ivermectin API Price utilized in the formulation of products. Ivermectin API Price is not always fixed or binding as the Ivermectin Price is obtained through a variety of data sources. The Ivermectin Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Mectizan manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Mectizan, including repackagers and relabelers. The FDA regulates Mectizan manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Mectizan 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 Mectizan manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Mectizan supplier is an individual or a company that provides Mectizan active pharmaceutical ingredient (API) or Mectizan finished formulations upon request. The Mectizan suppliers may include Mectizan API manufacturers, exporters, distributors and traders.
click here to find a list of Mectizan suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Mectizan DMF (Drug Master File) is a document detailing the whole manufacturing process of Mectizan active pharmaceutical ingredient (API) in detail. Different forms of Mectizan DMFs exist exist since differing nations have different regulations, such as Mectizan USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Mectizan DMF submitted to regulatory agencies in the US is known as a USDMF. Mectizan USDMF includes data on Mectizan's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Mectizan USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Mectizan 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 Mectizan Drug Master File in Japan (Mectizan JDMF) empowers Mectizan 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 Mectizan JDMF during the approval evaluation for pharmaceutical products. At the time of Mectizan 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 Mectizan 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 Mectizan Drug Master File in Korea (Mectizan KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Mectizan. The MFDS reviews the Mectizan KDMF as part of the drug registration process and uses the information provided in the Mectizan KDMF to evaluate the safety and efficacy of the drug.
After submitting a Mectizan 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 Mectizan API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Mectizan suppliers with KDMF on PharmaCompass.
A Mectizan CEP of the European Pharmacopoeia monograph is often referred to as a Mectizan Certificate of Suitability (COS). The purpose of a Mectizan CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Mectizan EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Mectizan to their clients by showing that a Mectizan CEP has been issued for it. The manufacturer submits a Mectizan CEP (COS) as part of the market authorization procedure, and it takes on the role of a Mectizan CEP holder for the record. Additionally, the data presented in the Mectizan CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Mectizan DMF.
A Mectizan CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Mectizan 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 Mectizan 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 Mectizan as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Mectizan 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 Mectizan 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 Mectizan and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Mectizan NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Mectizan suppliers with NDC on PharmaCompass.
Mectizan 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 Mectizan 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 Mectizan GMP manufacturer or Mectizan GMP API supplier for your needs.
A Mectizan CoA (Certificate of Analysis) is a formal document that attests to Mectizan's compliance with Mectizan specifications and serves as a tool for batch-level quality control.
Mectizan CoA mostly includes findings from lab analyses of a specific batch. For each Mectizan 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.
Mectizan may be tested according to a variety of international standards, such as European Pharmacopoeia (Mectizan EP), Mectizan JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Mectizan USP).
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