01 1Abbott Healthcare Products B. V.
02 1Danipharm A/S
03 2Fresenius Kabi iPSUM S. r. l.
01 2Lactulose
02 1Lactulose Crystals
03 1Lactulose Syrup
01 1Denmark
02 1U.S.A
03 2United Kingdom
Registration Number : 219MF10056
Registrant's Address : C. J. van Houtenlaan 36 1381 CP Weesp The Netherlands
Initial Date of Registration : 2007-03-05
Latest Date of Registration : 2024-05-22
Registration Number : 222MF10224
Registrant's Address : Englandsvej 350-356 DK-2770 Kastrup Denmark
Initial Date of Registration : 2010-09-07
Latest Date of Registration : 2010-09-07
Registration Number : 217MF11292
Registrant's Address : Piazza Maestri del Lavoro, 7 20063 Cernusco sul Naviglio (Milano), Italy
Initial Date of Registration : 2005-12-22
Latest Date of Registration : 2014-05-02
Registration Number : 217MF11291
Registrant's Address : via Roma, n. 108 20051 Cassina de'Pecchi (MI), Italy.
Initial Date of Registration : 2005-12-22
Latest Date of Registration : 2014-04-02
A Lactulose manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lactulose, including repackagers and relabelers. The FDA regulates Lactulose manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lactulose 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 Lactulose manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lactulose supplier is an individual or a company that provides Lactulose active pharmaceutical ingredient (API) or Lactulose finished formulations upon request. The Lactulose suppliers may include Lactulose API manufacturers, exporters, distributors and traders.
click here to find a list of Lactulose 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 Lactulose Drug Master File in Japan (Lactulose JDMF) empowers Lactulose 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 Lactulose JDMF during the approval evaluation for pharmaceutical products. At the time of Lactulose 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 Lactulose suppliers with JDMF on PharmaCompass.
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