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DRUG PRODUCT COMPOSITIONS0
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API SUPPLIERS
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USDMF
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DOSAGE - TABLET;ORAL - 10MG;100MG
USFDA APPLICATION NUMBER - 17555
DOSAGE - TABLET;ORAL - 25MG;100MG
USFDA APPLICATION NUMBER - 17555
DOSAGE - TABLET;ORAL - 25MG;250MG
USFDA APPLICATION NUMBER - 17555
DOSAGE - TABLET;ORAL - 25MG
USFDA APPLICATION NUMBER - 17830
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 25MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 25MG;100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19856
DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG...DOSAGE - TABLET, EXTENDED RELEASE;ORAL - 50MG;200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
USFDA APPLICATION NUMBER - 19856
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 23....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 23.75MG;95MG
USFDA APPLICATION NUMBER - 203312
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 36.25MG;145MG
USFDA APPLICATION NUMBER - 203312
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 48....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 48.75MG;195MG
USFDA APPLICATION NUMBER - 203312
DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 61....DOSAGE - CAPSULE, EXTENDED RELEASE;ORAL - 61.25MG;245MG
USFDA APPLICATION NUMBER - 203312
DOSAGE - TABLET;ORAL - 12.5MG;200MG;50MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 18.75MG;200MG;75MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 25MG;200MG;100MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 31.25MG;200MG;125MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 37.5MG;200MG;150MG
USFDA APPLICATION NUMBER - 21485
DOSAGE - TABLET;ORAL - 50MG;200MG;200MG
USFDA APPLICATION NUMBER - 21485
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ABOUT THIS PAGE
11
PharmaCompass offers a list of Carbidopa 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 Carbidopa manufacturer or Carbidopa supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Carbidopa manufacturer or Carbidopa supplier.
PharmaCompass also assists you with knowing the Carbidopa API Price utilized in the formulation of products. Carbidopa API Price is not always fixed or binding as the Carbidopa Price is obtained through a variety of data sources. The Carbidopa Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lodosin manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lodosin, including repackagers and relabelers. The FDA regulates Lodosin manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lodosin 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 Lodosin manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lodosin supplier is an individual or a company that provides Lodosin active pharmaceutical ingredient (API) or Lodosin finished formulations upon request. The Lodosin suppliers may include Lodosin API manufacturers, exporters, distributors and traders.
click here to find a list of Lodosin suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Lodosin DMF (Drug Master File) is a document detailing the whole manufacturing process of Lodosin active pharmaceutical ingredient (API) in detail. Different forms of Lodosin DMFs exist exist since differing nations have different regulations, such as Lodosin USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Lodosin DMF submitted to regulatory agencies in the US is known as a USDMF. Lodosin USDMF includes data on Lodosin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lodosin USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Lodosin 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 Lodosin Drug Master File in Japan (Lodosin JDMF) empowers Lodosin 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 Lodosin JDMF during the approval evaluation for pharmaceutical products. At the time of Lodosin 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 Lodosin 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 Lodosin Drug Master File in Korea (Lodosin KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lodosin. The MFDS reviews the Lodosin KDMF as part of the drug registration process and uses the information provided in the Lodosin KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lodosin 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 Lodosin API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lodosin suppliers with KDMF on PharmaCompass.
A Lodosin CEP of the European Pharmacopoeia monograph is often referred to as a Lodosin Certificate of Suitability (COS). The purpose of a Lodosin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Lodosin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Lodosin to their clients by showing that a Lodosin CEP has been issued for it. The manufacturer submits a Lodosin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Lodosin CEP holder for the record. Additionally, the data presented in the Lodosin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Lodosin DMF.
A Lodosin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Lodosin 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 Lodosin suppliers with CEP (COS) on PharmaCompass.
A Lodosin written confirmation (Lodosin WC) is an official document issued by a regulatory agency to a Lodosin manufacturer, verifying that the manufacturing facility of a Lodosin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lodosin APIs or Lodosin finished pharmaceutical products to another nation, regulatory agencies frequently require a Lodosin WC (written confirmation) as part of the regulatory process.
click here to find a list of Lodosin 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 Lodosin as an active pharmaceutical ingredient (API).
The FDA updates the NDC directory daily. The NDC numbers for Lodosin 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 Lodosin 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 Lodosin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lodosin NDC to their finished compounded human drug products, they may choose to do so.
click here to find a list of Lodosin suppliers with NDC on PharmaCompass.
Lodosin 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 Lodosin 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 Lodosin GMP manufacturer or Lodosin GMP API supplier for your needs.
A Lodosin CoA (Certificate of Analysis) is a formal document that attests to Lodosin's compliance with Lodosin specifications and serves as a tool for batch-level quality control.
Lodosin CoA mostly includes findings from lab analyses of a specific batch. For each Lodosin 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.
Lodosin may be tested according to a variety of international standards, such as European Pharmacopoeia (Lodosin EP), Lodosin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lodosin USP).
