01 1Katwijk Chemie bv
01 1Japanese Pharmacopoeia outside pemoline (production only)
01 1Netherlands
Pemoline (non-Japanese Pharmacopoeia) (for manufacturing only)
Registration Number : 219MF10057
Registrant's Address : Snijderstraat 6,2222 BA, Katwijk, ZH The Netherlands
Initial Date of Registration : 2007-03-05
Latest Date of Registration : 2016-02-08
A Pemoline manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Pemoline, including repackagers and relabelers. The FDA regulates Pemoline manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Pemoline 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 Pemoline manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Pemoline supplier is an individual or a company that provides Pemoline active pharmaceutical ingredient (API) or Pemoline finished formulations upon request. The Pemoline suppliers may include Pemoline API manufacturers, exporters, distributors and traders.
click here to find a list of Pemoline 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 Pemoline Drug Master File in Japan (Pemoline JDMF) empowers Pemoline 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 Pemoline JDMF during the approval evaluation for pharmaceutical products. At the time of Pemoline 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 Pemoline suppliers with JDMF on PharmaCompass.
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