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