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USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
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Drugs in Development
Lead Product(s) : Ivermectin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Senores Pharmaceuticals
Deal Size : Inapplicable
Deal Type : Inapplicable
Dr. Reddy's Laboratories and Senores Pharmaceuticals Launch Ivermectin Tablets in US
Details : Stromectol-Generic (ivermectin) is a glutamate-gated chloride channel modulator, small molecule drug candidate, which is indicated for the treatment of patients with strongyloidiasis & onchocerciasis.
Product Name : Stromectol-Generic
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
November 26, 2024
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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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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.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Ivermectin manufacturer or Ivermectin supplier.
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 Ivermectin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ivermectin, including repackagers and relabelers. The FDA regulates Ivermectin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ivermectin 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 Ivermectin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ivermectin supplier is an individual or a company that provides Ivermectin active pharmaceutical ingredient (API) or Ivermectin finished formulations upon request. The Ivermectin suppliers may include Ivermectin API manufacturers, exporters, distributors and traders.
click here to find a list of Ivermectin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Ivermectin DMF (Drug Master File) is a document detailing the whole manufacturing process of Ivermectin active pharmaceutical ingredient (API) in detail. Different forms of Ivermectin DMFs exist exist since differing nations have different regulations, such as Ivermectin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Ivermectin DMF submitted to regulatory agencies in the US is known as a USDMF. Ivermectin USDMF includes data on Ivermectin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Ivermectin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Ivermectin 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 Ivermectin Drug Master File in Japan (Ivermectin JDMF) empowers Ivermectin 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 Ivermectin JDMF during the approval evaluation for pharmaceutical products. At the time of Ivermectin 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 Ivermectin 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 Ivermectin Drug Master File in Korea (Ivermectin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ivermectin. The MFDS reviews the Ivermectin KDMF as part of the drug registration process and uses the information provided in the Ivermectin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ivermectin 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 Ivermectin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ivermectin suppliers with KDMF on PharmaCompass.
A Ivermectin CEP of the European Pharmacopoeia monograph is often referred to as a Ivermectin Certificate of Suitability (COS). The purpose of a Ivermectin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Ivermectin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Ivermectin to their clients by showing that a Ivermectin CEP has been issued for it. The manufacturer submits a Ivermectin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Ivermectin CEP holder for the record. Additionally, the data presented in the Ivermectin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Ivermectin DMF.
A Ivermectin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Ivermectin 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 Ivermectin 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 Ivermectin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Ivermectin 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 Ivermectin 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 Ivermectin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Ivermectin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Ivermectin suppliers with NDC on PharmaCompass.
Ivermectin 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 Ivermectin 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 Ivermectin GMP manufacturer or Ivermectin GMP API supplier for your needs.
A Ivermectin CoA (Certificate of Analysis) is a formal document that attests to Ivermectin's compliance with Ivermectin specifications and serves as a tool for batch-level quality control.
Ivermectin CoA mostly includes findings from lab analyses of a specific batch. For each Ivermectin 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.
Ivermectin may be tested according to a variety of international standards, such as European Pharmacopoeia (Ivermectin EP), Ivermectin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Ivermectin USP).
