Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
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Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
Registration Number : 306MF10129
Registrant's Address : No. 11 Chengen Road, Pubagan Town, Sanmen, Zhejiang, China
Initial Date of Registration : 2024-09-25
Latest Date of Registration : 2024-09-25
Zhejiang Hengkang Pharm Group is a dynamic pharmaceutical entity, spanning drug research, large-scale production, and global marketing.
Registration Number : 222MF10148
Registrant's Address : No. 1 Longxiang Road, Hairun Street, Sanmen, Zhejiang, China
Initial Date of Registration : 2010-04-28
Latest Date of Registration : 2010-04-28
A Pranlukast Hydrate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pranlukast Hydrate, including repackagers and relabelers. The FDA regulates Pranlukast Hydrate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pranlukast Hydrate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
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A Pranlukast Hydrate supplier is an individual or a company that provides Pranlukast Hydrate active pharmaceutical ingredient (API) or Pranlukast Hydrate finished formulations upon request. The Pranlukast Hydrate suppliers may include Pranlukast Hydrate 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 Pranlukast Hydrate Drug Master File in Japan (Pranlukast Hydrate JDMF) empowers Pranlukast Hydrate 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 Pranlukast Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Pranlukast Hydrate 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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