01 1Edmond Pharma s. r. l.
02 2Ohara Pharmaceutical Co., Ltd.
03 2Prince Pharmaceutical Co. , Ltd.
04 2Sumitomo Chemical Co., Ltd.
01 1Japanese Pharmacopoeia tulobuterol (production only)
02 1Japanese Pharmacopoeia tulobuterol hydrochloride
03 1Japanese Pharmacopoeia tulobuterol hydrochloride (production only)
04 4Tulobuterol
01 4Japan
02 1Sweden
03 2Taiwan
Registration Number : 218MF10469
Registrant's Address : 121-15 Toriiino, Koka-cho, Koka City, Shiga Prefecture
Initial Date of Registration : 2006-04-27
Latest Date of Registration : 2007-01-17
Japanese Pharmacopoeia Tulobuterol Hydrochloride (For manufacturing only)
Registration Number : 219MF10269
Registrant's Address : 121-15 Toriiino, Koka-cho, Koka City, Shiga Prefecture
Initial Date of Registration : 2007-08-16
Latest Date of Registration : 2007-08-16
Japanese Pharmacopoeia Tulobuterol (for manufacturing only)
Registration Number : 228MF10109
Registrant's Address : 9F, No. 107, Sec. 3, Chung-Shin Rd. San-Chung City, Taipei Hsien, Taiwan.
Initial Date of Registration : 2016-06-08
Latest Date of Registration : 2016-06-08
Registration Number : 303MF10132
Registrant's Address : No. 168, Keyun S. Rd. , Huwei Township, Yunlin County 632007, Taiwan, R. O. C.
Initial Date of Registration : 2021-08-16
Latest Date of Registration : 2021-08-16
Registration Number : 218MF10871
Registrant's Address : Strada Statale dei Giovi, 131-20037 Paderno Dugnano (MI) - Italy
Initial Date of Registration : 2006-11-06
Latest Date of Registration : 2006-11-06
Japanese Pharmacopoeia Tulobuterol Hydrochloride
Registration Number : 219MF10229
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2007-07-06
Latest Date of Registration : 2007-07-06
Registration Number : 217MF10099
Registrant's Address : 2-27-1 Shinkawa, Chuo-ku, Tokyo
Initial Date of Registration : 2005-05-23
Latest Date of Registration : 2007-07-06
A Tulobuterol manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Tulobuterol, including repackagers and relabelers. The FDA regulates Tulobuterol manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Tulobuterol 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 Tulobuterol manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Tulobuterol supplier is an individual or a company that provides Tulobuterol active pharmaceutical ingredient (API) or Tulobuterol finished formulations upon request. The Tulobuterol suppliers may include Tulobuterol API manufacturers, exporters, distributors and traders.
click here to find a list of Tulobuterol 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 Tulobuterol Drug Master File in Japan (Tulobuterol JDMF) empowers Tulobuterol 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 Tulobuterol JDMF during the approval evaluation for pharmaceutical products. At the time of Tulobuterol 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 Tulobuterol suppliers with JDMF on PharmaCompass.
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