01 1Olon S. p. A.
01 1Hydrochloric acid levobunolol
01 1Italy
Registration Number : 218MF10957
Registrant's Address : Strada Rivoltana Km 6/7 20090 Rodano Milano Italy
Initial Date of Registration : 2006-12-01
Latest Date of Registration : 2020-03-09
A Levobunolol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Levobunolol, including repackagers and relabelers. The FDA regulates Levobunolol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Levobunolol 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 Levobunolol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Levobunolol supplier is an individual or a company that provides Levobunolol active pharmaceutical ingredient (API) or Levobunolol finished formulations upon request. The Levobunolol suppliers may include Levobunolol API manufacturers, exporters, distributors and traders.
click here to find a list of Levobunolol 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 Levobunolol Drug Master File in Japan (Levobunolol JDMF) empowers Levobunolol 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 Levobunolol JDMF during the approval evaluation for pharmaceutical products. At the time of Levobunolol 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 Levobunolol suppliers with JDMF on PharmaCompass.
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