01 1COSMA S. P. A.
02 1Ipca Laboratories Limited
01 1Propranolol hydrochloride
02 1Propranolol hydrochloride (production only)
01 1India
02 1Italy
Propranolol hydrochloride (for manufacturing only)
Registration Number : 221MF10278
Registrant's Address : Via Colleoni 15/17, 24040 Ciserano (BG)・Italy
Initial Date of Registration : 2009-12-18
Latest Date of Registration : 2016-03-11
Registration Number : 218MF10174
Registrant's Address : 48, Kandivli Industrial Estate, Kandivli (W), Mumbai 400 067, India
Initial Date of Registration : 2006-02-08
Latest Date of Registration : 2006-10-20
A Inderal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Inderal, including repackagers and relabelers. The FDA regulates Inderal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Inderal 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 Inderal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Inderal supplier is an individual or a company that provides Inderal active pharmaceutical ingredient (API) or Inderal finished formulations upon request. The Inderal suppliers may include Inderal API manufacturers, exporters, distributors and traders.
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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 Inderal Drug Master File in Japan (Inderal JDMF) empowers Inderal 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 Inderal JDMF during the approval evaluation for pharmaceutical products. At the time of Inderal JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.
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