01 1LEO Pharma Southport Pty Ltd
01 1Leo Pharma Co., Ltd.
01 1Ingenolmebutate
01 1Denmark
Registrant Name : Leo Pharma Co., Ltd.
Registration Date : 2013-10-29
Registration Number : No. 4726-1-ND
Manufacturer Name : LEO Pharma Southport Pty Ltd
Manufacturer Address : 18 Olympic Circuit & 5 Goodyear Street, Southport, Queensland 4215, Australia
A Ingenol Mebutate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Ingenol Mebutate, including repackagers and relabelers. The FDA regulates Ingenol Mebutate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Ingenol Mebutate 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 Ingenol Mebutate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Ingenol Mebutate supplier is an individual or a company that provides Ingenol Mebutate active pharmaceutical ingredient (API) or Ingenol Mebutate finished formulations upon request. The Ingenol Mebutate suppliers may include Ingenol Mebutate API manufacturers, exporters, distributors and traders.
click here to find a list of Ingenol Mebutate 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 Ingenol Mebutate Drug Master File in Korea (Ingenol Mebutate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Ingenol Mebutate. The MFDS reviews the Ingenol Mebutate KDMF as part of the drug registration process and uses the information provided in the Ingenol Mebutate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Ingenol Mebutate 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 Ingenol Mebutate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Ingenol Mebutate suppliers with KDMF on PharmaCompass.
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