01 2Olon SpA
01 1IMCD Korea Co., Ltd.
02 1Korea Menarini Co., Ltd.
01 2Octylonium bromide
01 2Italy
Registrant Name : Korea Menarini Co., Ltd.
Registration Date : 2021-06-11
Registration Number : 20210611-209-J-1023
Manufacturer Name : Olon SpA
Manufacturer Address : Via Livelli, 1-26852 Casaletto Lodigiano fraz.Mairano (LO)-Italy
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2019-03-18
Registration Number : 20190318-209-J-172
Manufacturer Name : Olon SpA
Manufacturer Address : Via Milano, 186 20024 garbagnate Milanese (MI), Italy
91
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A Spasmomen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Spasmomen, including repackagers and relabelers. The FDA regulates Spasmomen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Spasmomen API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Spasmomen supplier is an individual or a company that provides Spasmomen active pharmaceutical ingredient (API) or Spasmomen finished formulations upon request. The Spasmomen suppliers may include Spasmomen API manufacturers, exporters, distributors and traders.
click here to find a list of Spasmomen suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 Spasmomen Drug Master File in Korea (Spasmomen KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Spasmomen. The MFDS reviews the Spasmomen KDMF as part of the drug registration process and uses the information provided in the Spasmomen KDMF to evaluate the safety and efficacy of the drug.
After submitting a Spasmomen 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 Spasmomen API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Spasmomen suppliers with KDMF on PharmaCompass.
