Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
01 1Pharmaceutical Works POLPHARMA S. A.
02 1TAPI Croatia Industries Ltd.
01 1Etodolac
02 1Etodolac "Teva / PLIVA2"
01 1Croatia
02 1Poland
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registration Number : 225MF10101
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2013-05-10
Latest Date of Registration : 2023-07-26
Registration Number : 227MF10244
Registrant's Address : Prudnicka cesta 54, Savski Marof, County Brdovec 10291 Prigorje Brdovecko, Croatia
Initial Date of Registration : 2015-10-07
Latest Date of Registration : 2015-10-07
A Etodolac manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Etodolac, including repackagers and relabelers. The FDA regulates Etodolac manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Etodolac 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 Etodolac manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Etodolac supplier is an individual or a company that provides Etodolac active pharmaceutical ingredient (API) or Etodolac finished formulations upon request. The Etodolac suppliers may include Etodolac API manufacturers, exporters, distributors and traders.
click here to find a list of Etodolac 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 Etodolac Drug Master File in Japan (Etodolac JDMF) empowers Etodolac 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 Etodolac JDMF during the approval evaluation for pharmaceutical products. At the time of Etodolac 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 Etodolac suppliers with JDMF on PharmaCompass.
We have 2 companies offering Etodolac
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