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 Lamotrigine manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lamotrigine, including repackagers and relabelers. The FDA regulates Lamotrigine manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lamotrigine 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 Lamotrigine manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Lamotrigine supplier is an individual or a company that provides Lamotrigine active pharmaceutical ingredient (API) or Lamotrigine finished formulations upon request. The Lamotrigine suppliers may include Lamotrigine API manufacturers, exporters, distributors and traders.
click here to find a list of Lamotrigine 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 Lamotrigine Drug Master File in Japan (Lamotrigine JDMF) empowers Lamotrigine 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 Lamotrigine JDMF during the approval evaluation for pharmaceutical products. At the time of Lamotrigine 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 Lamotrigine suppliers with JDMF on PharmaCompass.
We have 5 companies offering Lamotrigine
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