01 1Alembic Pharmaceuticals Limited
02 1Alives Life Sciences Limited
03 1Synthimed Labs Private Limited
04 1URQUIMA S. A.
01 1ROPINIROLE HYDROCHLORIDE
02 3Ropinirole hydrochloride
01 3India
02 1Spain
Registration Number : 228MF10173
Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India
Initial Date of Registration : 2016-08-29
Latest Date of Registration : 2019-05-15
Registration Number : 227MF10031
Registrant's Address : 4th Floor, OIA House, 470, Cardinal Gracious Road, Andheri East Mumbai 400099, Mahara...
Initial Date of Registration : 2015-01-23
Latest Date of Registration : 2015-01-23
Registration Number : 227MF10080
Registrant's Address : Village-Bhagwanpur, Barwala Road, Derabassi-140 507 District-S. A. S. Nagar (Mohali)P...
Initial Date of Registration : 2015-03-12
Latest Date of Registration : 2021-10-13
Registration Number : 227MF10077
Registrant's Address : Poli(')gon Industrial Riera de Caldes Avinguda Cami(') Reial 51-57 08184 Palau-Solita...
Initial Date of Registration : 2015-03-12
Latest Date of Registration : 2015-03-12
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A BS-1020 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of BS-1020, including repackagers and relabelers. The FDA regulates BS-1020 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. BS-1020 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 BS-1020 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, and COA related information on PhamaCompass.
A BS-1020 supplier is an individual or a company that provides BS-1020 active pharmaceutical ingredient (API) or BS-1020 finished formulations upon request. The BS-1020 suppliers may include BS-1020 API manufacturers, exporters, distributors and traders.
click here to find a list of BS-1020 suppliers with USDMF, JDMF, KDMF, CEP, GMP, and COA 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 BS-1020 Drug Master File in Japan (BS-1020 JDMF) empowers BS-1020 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 BS-1020 JDMF during the approval evaluation for pharmaceutical products. At the time of BS-1020 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 BS-1020 suppliers with JDMF on PharmaCompass.
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