01 1Megafine Pharma (P) Limited
01 1Piranterupamo salt (production only)
01 1India
Pyrantel pamoate (for manufacturing purposes only)
Registration Number : 221MF10046
Registrant's Address : Sethna 4th floor 55 Maharshi karve road Marine Lines,Mumbai-400002,INDIA
Initial Date of Registration : 2009-02-25
Latest Date of Registration : 2018-10-12
A Pyrantel Pamoate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pyrantel Pamoate, including repackagers and relabelers. The FDA regulates Pyrantel Pamoate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pyrantel Pamoate 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 Pyrantel Pamoate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pyrantel Pamoate supplier is an individual or a company that provides Pyrantel Pamoate active pharmaceutical ingredient (API) or Pyrantel Pamoate finished formulations upon request. The Pyrantel Pamoate suppliers may include Pyrantel Pamoate API manufacturers, exporters, distributors and traders.
click here to find a list of Pyrantel Pamoate 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 Pyrantel Pamoate Drug Master File in Japan (Pyrantel Pamoate JDMF) empowers Pyrantel Pamoate 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 Pyrantel Pamoate JDMF during the approval evaluation for pharmaceutical products. At the time of Pyrantel Pamoate 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 Pyrantel Pamoate suppliers with JDMF on PharmaCompass.
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