01 1Curia Spain S. A. U.
02 1Newchem S. p. A.
03 1STEROID S. p. A.
01 2Hydrocortisone butyrate
02 1Japanese Pharmacopoeia hydrocortisone butyrate (production only)
01 2Italy
02 1U.S.A
Registration Number : 222MF10284
Registrant's Address : Parque Tecnologico-Parcela 105 Boecillo (Valladolid) Spain
Initial Date of Registration : 2010-12-27
Latest Date of Registration : 2020-04-02
Registration Number : 223MF10022
Registrant's Address : Via de Amicis 47, 20123 Milano, Italy
Initial Date of Registration : 2011-02-08
Latest Date of Registration : 2011-02-08
Japanese Pharmacopoeia Hydrocortisone Butyrate (For manufacturing only)
Registration Number : 222MF10261
Registrant's Address : Viale Spagna, 156 Cologno Monzese (MI) - ITALY
Initial Date of Registration : 2010-11-29
Latest Date of Registration : 2010-11-29
A Hydrocortisone Butyrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Hydrocortisone Butyrate, including repackagers and relabelers. The FDA regulates Hydrocortisone Butyrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Hydrocortisone Butyrate 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 Hydrocortisone Butyrate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Hydrocortisone Butyrate supplier is an individual or a company that provides Hydrocortisone Butyrate active pharmaceutical ingredient (API) or Hydrocortisone Butyrate finished formulations upon request. The Hydrocortisone Butyrate suppliers may include Hydrocortisone Butyrate API manufacturers, exporters, distributors and traders.
click here to find a list of Hydrocortisone Butyrate 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 Hydrocortisone Butyrate Drug Master File in Japan (Hydrocortisone Butyrate JDMF) empowers Hydrocortisone Butyrate 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 Hydrocortisone Butyrate JDMF during the approval evaluation for pharmaceutical products. At the time of Hydrocortisone Butyrate 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 Hydrocortisone Butyrate suppliers with JDMF on PharmaCompass.
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