US DMFs Filed
USA (Orange Book)
PharmaCompass offers a list of Apalutamide 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 Apalutamide manufacturer or Apalutamide supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Apalutamide manufacturer or Apalutamide supplier.
PharmaCompass also assists you with knowing the Apalutamide API Price utilized in the formulation of products. Apalutamide API Price is not always fixed or binding as the Apalutamide Price is obtained through a variety of data sources. The Apalutamide Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Apalutamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Apalutamide, including repackagers and relabelers. The FDA regulates Apalutamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Apalutamide 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 Apalutamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Apalutamide supplier is an individual or a company that provides Apalutamide active pharmaceutical ingredient (API) or Apalutamide finished formulations upon request. The Apalutamide suppliers may include Apalutamide API manufacturers, exporters, distributors and traders.
CLICK HERE to find a list of Apalutamide 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 Apalutamide Drug Master File in Korea (Apalutamide KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Apalutamide. The MFDS reviews the Apalutamide KDMF as part of the drug registration process and uses the information provided in the Apalutamide KDMF to evaluate the safety and efficacy of the drug.
After submitting a Apalutamide 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 Apalutamide API can apply through the Korea Drug Master File (KDMF).
CLICK HERE to find a list of Apalutamide suppliers with KDMF on PharmaCompass.
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