01 1BASILDON CHEMICAL COMPANY LIMITED
02 4Eigenmann & Veronelli SPA
01 2Ace Biopharm Co., Ltd.
02 1IMCD Korea Co., Ltd.
03 1Sungjin Exim Co., Ltd.
04 1Sungwoo Chemical Co., Ltd.
01 5Simethicone
01 4Italy
02 1United Kingdom
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2022-01-14
Registration Number : 20220114-211-J-1213
Manufacturer Name : BASILDON CHEMICAL COMPANY LI...
Manufacturer Address : Kimber Road Abingdon Oxon. OX14 1RZ UK
Registrant Name : Sungjin Exim Co., Ltd.
Registration Date : 2021-05-06
Registration Number : 20210506-211-J-780
Manufacturer Name : Eigenmann & Veronelli SPA
Manufacturer Address : San Martino-Trecate(NO)-Via Vigevano 63/A, 28069, Italy
Registrant Name : Sungwoo Chemical Co., Ltd.
Registration Date : 2023-06-02
Registration Number : 20210506-211-J-780(2)
Manufacturer Name : Eigenmann & Veronelli SPA
Manufacturer Address : San Martino-Trecate(NO)-Via Vigevano 63/A, 28069, Italy
Registrant Name : IMCD Korea Co., Ltd.
Registration Date : 2022-11-17
Registration Number : 20210506-211-J-780(1)
Manufacturer Name : Eigenmann & Veronelli SPA
Manufacturer Address : San Martino-Trecate(NO)-Via Vigevano 63/A, 28069, Italy
Registrant Name : Ace Biopharm Co., Ltd.
Registration Date : 2023-10-19
Registration Number : 20210506-211-J-780(3)
Manufacturer Name : Eigenmann & Veronelli SPA
Manufacturer Address : San Martino-Trecate(NO)-Via Vigevano 63/A, 28069, Italy
A Simethicone manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Simethicone, including repackagers and relabelers. The FDA regulates Simethicone manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Simethicone 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 Simethicone manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Simethicone supplier is an individual or a company that provides Simethicone active pharmaceutical ingredient (API) or Simethicone finished formulations upon request. The Simethicone suppliers may include Simethicone API manufacturers, exporters, distributors and traders.
click here to find a list of Simethicone 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 Simethicone Drug Master File in Korea (Simethicone KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Simethicone. The MFDS reviews the Simethicone KDMF as part of the drug registration process and uses the information provided in the Simethicone KDMF to evaluate the safety and efficacy of the drug.
After submitting a Simethicone 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 Simethicone API can apply through the Korea Drug Master File (KDMF).
click here to find a list of Simethicone suppliers with KDMF on PharmaCompass.
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