01 2BASILDON CHEMICAL CO. LIMITED
02 1DDP Specialty Electronic Materials US 9, LLC
01 1AFC2-2671 (Simeticone)
02 1BC Simeticone Antifoam PD30S (Simeticone Emulsion)
03 1LiveoTM Q7-2243 LVA, Simeticone USP
01 1U.S.A
02 2United Kingdom
BC Simethicone Antifoam PD30S (Simethicone Emulsion)
Registration Number : 302MF20002
Registrant's Address : Kimber Road, Abingdon, Oxon, OX14 1RZ, United Kingdom
Initial Date of Registration : 2020-08-18
Latest Date of Registration : 2022-10-19
Registration Number : 302MF20001
Registrant's Address : Kimber Road, Abingdon, Oxon, OX14 1RZ, United Kingdom
Initial Date of Registration : 2020-08-05
Latest Date of Registration : 2020-08-05
LiveoT.M. Q7-2243 LVA, Simethicone USP
Registration Number : 303MF10114
Registrant's Address : 974 Center Road, Wilmington, DE 19805, USA
Initial Date of Registration : 2021-07-16
Latest Date of Registration : 2021-07-16
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.
The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.
The Simethicone Drug Master File in Japan (Simethicone JDMF) empowers Simethicone API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).
PMDA reviews the Simethicone JDMF during the approval evaluation for pharmaceutical products. At the time of Simethicone JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
click here to find a list of Simethicone suppliers with JDMF on PharmaCompass.
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