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PharmaCompass offers a list of Lorlatinib 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 Lorlatinib manufacturer or Lorlatinib supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lorlatinib manufacturer or Lorlatinib supplier.
PharmaCompass also assists you with knowing the Lorlatinib API Price utilized in the formulation of products. Lorlatinib API Price is not always fixed or binding as the Lorlatinib Price is obtained through a variety of data sources. The Lorlatinib Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Lorlatinib manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lorlatinib, including repackagers and relabelers. The FDA regulates Lorlatinib manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lorlatinib 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 Lorlatinib manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lorlatinib supplier is an individual or a company that provides Lorlatinib active pharmaceutical ingredient (API) or Lorlatinib finished formulations upon request. The Lorlatinib suppliers may include Lorlatinib API manufacturers, exporters, distributors and traders.
click here to find a list of Lorlatinib suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information 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 Lorlatinib Drug Master File in Korea (Lorlatinib KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lorlatinib. The MFDS reviews the Lorlatinib KDMF as part of the drug registration process and uses the information provided in the Lorlatinib KDMF to evaluate the safety and efficacy of the drug.
After submitting a Lorlatinib 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 Lorlatinib API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Lorlatinib suppliers with KDMF on PharmaCompass.
Lorlatinib 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 Lorlatinib 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 Lorlatinib GMP manufacturer or Lorlatinib GMP API supplier for your needs.
A Lorlatinib CoA (Certificate of Analysis) is a formal document that attests to Lorlatinib's compliance with Lorlatinib specifications and serves as a tool for batch-level quality control.
Lorlatinib CoA mostly includes findings from lab analyses of a specific batch. For each Lorlatinib 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.
Lorlatinib may be tested according to a variety of international standards, such as European Pharmacopoeia (Lorlatinib EP), Lorlatinib JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lorlatinib USP).
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