01 1DIVI'S LABORATORIES LIMITED
02 1HETERO DRUGS LIMITED.
03 1HIKAL LIMITED.
04 1MSN Pharmachem Private Limited.
05 1Sumitomo Chemical Co., Ltd.
06 1Venkata Narayana Active Ingredients Private Limited
01 5Lacosamide
02 1Lacosamide USP
01 5India
02 1Japan
Registration Number : 306MF10100
Registrant's Address : 1-72/23(P)/DIVIS/303, Divi Towers, Cyber Hills, Gachibowli, Hyderabad-500 032, ...
Initial Date of Registration : 2024-07-17
Latest Date of Registration : 2024-07-17
Registration Number : 306MF10110
Registrant's Address : 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad-500 018, Telang...
Initial Date of Registration : 2024-08-07
Latest Date of Registration : 2024-08-07
Registration Number : 306MF10102
Registrant's Address : Great Eastern Chambers, CBD Belapur, Navi Mumbai-400 614, India
Initial Date of Registration : 2024-07-17
Latest Date of Registration : 2024-07-17
Registration Number : 306MF10101
Registrant's Address : Plot No: C-24, Sanath Nagar Industrial Estate, Sanath Nagar, Hyderabad, Telangana, In...
Initial Date of Registration : 2024-07-17
Latest Date of Registration : 2024-07-17
Registration Number : 306MF10075
Registrant's Address : 2-7-1 Nihonbashi, Chuo-ku, Tokyo
Initial Date of Registration : 2024-06-06
Latest Date of Registration : 2024-06-06
Registration Number : 306MF10107
Registrant's Address : New No. 60, Old No. 35, Venkata Narayana Road, T. NagarChennai 600017 India
Initial Date of Registration : 2024-07-31
Latest Date of Registration : 2024-07-31
A Lacosamide manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lacosamide, including repackagers and relabelers. The FDA regulates Lacosamide manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lacosamide 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 Lacosamide manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lacosamide supplier is an individual or a company that provides Lacosamide active pharmaceutical ingredient (API) or Lacosamide finished formulations upon request. The Lacosamide suppliers may include Lacosamide API manufacturers, exporters, distributors and traders.
click here to find a list of Lacosamide 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 Lacosamide Drug Master File in Japan (Lacosamide JDMF) empowers Lacosamide 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 Lacosamide JDMF during the approval evaluation for pharmaceutical products. At the time of Lacosamide 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 Lacosamide suppliers with JDMF on PharmaCompass.
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