01 1Solara Active Pharma Sciences Limited
01 1Rotigotine
01 1India
Registration Number : 306MF10057
Registrant's Address : No 120 A&B, 36, 120P & 121, Industrial Area, Baikampady, New Mangalore - 575011, Karn...
Initial Date of Registration : 2024-04-18
Latest Date of Registration : 2024-04-18
A Rotigotine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Rotigotine, including repackagers and relabelers. The FDA regulates Rotigotine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Rotigotine 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 Rotigotine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Rotigotine supplier is an individual or a company that provides Rotigotine active pharmaceutical ingredient (API) or Rotigotine finished formulations upon request. The Rotigotine suppliers may include Rotigotine API manufacturers, exporters, distributors and traders.
click here to find a list of Rotigotine 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 Rotigotine Drug Master File in Japan (Rotigotine JDMF) empowers Rotigotine 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 Rotigotine JDMF during the approval evaluation for pharmaceutical products. At the time of Rotigotine 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 Rotigotine suppliers with JDMF on PharmaCompass.
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