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 1Alembic Pharmaceuticals Limited
03 1Aurobindo Pharma Limited
04 1Syn-Tech Chem. & Pharm. Co. , Ltd.
05 1Tateyama Chemical Co., Ltd.
01 4Lamotrigine
02 1Lamotrigine "Tateyama"
01 2India
02 1Japan
03 1Poland
04 1Taiwan
Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
Registration Number : 228MF10228
Registrant's Address : 19 Pellinska Str. 83-200 Starogard Gdanski POLAND
Initial Date of Registration : 2016-12-14
Latest Date of Registration : 2016-12-14
Registration Number : 229MF10012
Registrant's Address : Alembic Road, Vadodara 390 003, Gujarat, India
Initial Date of Registration : 2017-01-23
Latest Date of Registration : 2018-08-08
Registration Number : 229MF10046
Registrant's Address : Plot No. 2, Maitrivihar, Ameerpet, Hyderabad Telangana, India
Initial Date of Registration : 2017-02-20
Latest Date of Registration : 2017-02-20
Registration Number : 228MF10086
Registrant's Address : No. 168 Kai-Yuan Rd. , Hsin-Ying Tainan City, 73055. Taiwan
Initial Date of Registration : 2016-04-12
Latest Date of Registration : 2019-07-26
Registration Number : 228MF10222
Registrant's Address : 1133 Oe, Imizu City, Toyama Prefecture
Initial Date of Registration : 2016-11-22
Latest Date of Registration : 2016-11-22
A Lamictal manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lamictal, including repackagers and relabelers. The FDA regulates Lamictal manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lamictal 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 Lamictal manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lamictal supplier is an individual or a company that provides Lamictal active pharmaceutical ingredient (API) or Lamictal finished formulations upon request. The Lamictal suppliers may include Lamictal API manufacturers, exporters, distributors and traders.
click here to find a list of Lamictal 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 Lamictal Drug Master File in Japan (Lamictal JDMF) empowers Lamictal 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 Lamictal JDMF during the approval evaluation for pharmaceutical products. At the time of Lamictal 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 Lamictal suppliers with JDMF on PharmaCompass.
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