01 1Janssen Pharmaceutica NV
02 1Janssen Pharmaceutical Sciences Unlimited Company
01 2Korea Janssen Co., Ltd.
01 2Paliperidone palmitate
01 2U.S.A
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2010-05-27
Registration Number : Su217-12-ND
Manufacturer Name : Janssen Pharmaceutica NV
Manufacturer Address : Turnhoutseweg 30, B-2340 Beerse, Belgium
Registrant Name : Korea Janssen Co., Ltd.
Registration Date : 2011-09-16
Registration Number : Su217-13-ND
Manufacturer Name : Janssen Pharmaceutical Scien...
Manufacturer Address : Little Island Industrial EST., Little Island, Co. Cork, Ireland
A Paliperidone Palmitate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Paliperidone Palmitate, including repackagers and relabelers. The FDA regulates Paliperidone Palmitate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Paliperidone Palmitate 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 Paliperidone Palmitate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Paliperidone Palmitate supplier is an individual or a company that provides Paliperidone Palmitate active pharmaceutical ingredient (API) or Paliperidone Palmitate finished formulations upon request. The Paliperidone Palmitate suppliers may include Paliperidone Palmitate API manufacturers, exporters, distributors and traders.
click here to find a list of Paliperidone Palmitate 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 Paliperidone Palmitate Drug Master File in Korea (Paliperidone Palmitate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Paliperidone Palmitate. The MFDS reviews the Paliperidone Palmitate KDMF as part of the drug registration process and uses the information provided in the Paliperidone Palmitate KDMF to evaluate the safety and efficacy of the drug.
After submitting a Paliperidone Palmitate 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 Paliperidone Palmitate API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Paliperidone Palmitate suppliers with KDMF on PharmaCompass.
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