Lamotrigine

CAS number： 84057-84-1

Molecular formula： C9H7N5Cl2

molecular weight： 256.09

Chemical structure：

Producers shown on SFDA

(Record date:30/08/2021）

Producer	Documents	GMP Valid till(based on SFDA)
Zhejiang Huahai Pharmaceutical Co., Ltd.	GMP, DMF	Valid till October 2024
Sanjin Group Hunan Sanjin Pharmaceutical Co., Ltd.	GMP	Valid till January 2020

Producers shown on EP

(Quoted from EP website；record date:30/08/2021）

Substance	Certificate Holder	Certificate Number	Issue Date	Status	End date	Type
Lamotrigine	CIPLA LIMITED IN 400 013 Mumbai	R1-CEP 2010-212-Rev 01	23/01/2020	VALID	/	Chemistry
Lamotrigine	IPCA Laboratories Limited IN 400 067 Mumbai	R0-CEP 2018-293-Rev 00	18/03/2021	VALID	/	Chemistry
Lamotrigine	JUBILANT GENERICS LIMITED IN 571 302 Nanjangud	R1-CEP 2009-162-Rev 01	14/01/2019	VALID	/	Chemistry
Lamotrigine	ARAGEN LIFE SCIENCES PRIVATE LIMITED IN 500 076 Hyderabad	R1-CEP 2010-249-Rev 02	22/02/2021	VALID	/	Chemistry
Lamotrigine	SEQUEL PHARMACHEM PRIVATE LTD. IN 400 706 Nerul	R0-CEP 2009-107-Rev 00	11/04/2011	EXPIRED	25/04/2016	Chemistry
Lamotrigine	UNIMARK REMEDIES LIMITED IN 400 099 Mumbai	R1-CEP 2009-278-Rev 00	26/02/2016	SUSPENDED	27/04/2021	Chemistry
Lamotrigine	ALEMBIC PHARMACEUTICALS LIMITED IN 390 003 Vadodara	R1-CEP 2011-010-Rev 01	02/04/2020	VALID	/	Chemistry
Lamotrigine	PHARMACEUTICAL WORKS POLPHARMA S.A. PL 83-200 Starogard Gdanski	R1-CEP 2010-128-Rev 01	11/03/2020	VALID	/	Chemistry
Lamotrigine	CADILA HEALTHCARE LIMITED IN 391 440 Dabhasa Village	R0-CEP 2018-295-Rev 00	17/03/2021	VALID	/	Chemistry
Lamotrigine	Unichem Laboratories Limited IN 400 102 Mumbai	R1-CEP 2009-376-Rev 00	05/02/2016	VALID	/	Chemistry
Lamotrigine	RA CHEM PHARMA LIMITED IN 500 037 Hyderabad	R1-CEP 2008-261-Rev 01	07/07/2015	VALID	/	Chemistry
Lamotrigine	IOL CHEMICALS AND PHARMACEUTICALS LTD IN 148 101 Fatehgarh Channa Village	R1-CEP 2013-066-Rev 00	14/02/2020	VALID	/	Chemistry
Lamotrigine	MYLAN LABORATORIES LIMITED IN 500 096 Hyderabad	R1-CEP 2009-157-Rev 01	07/09/2017	VALID	/	Chemistry
Lamotrigine	AUROBINDO PHARMA LIMITED IN 500 038 Hyderabad	R1-CEP 2008-010-Rev 03	15/03/2019	VALID	/	Chemistry
Lamotrigine	CTX LIFE SCIENCES PVT. LIMITED IN 394 230 Surat	R1-CEP 2011-168-Rev 02	26/01/2021	VALID	/	Chemistry
Lamotrigine	ZHEJIANG HUAHAI PHARMACEUTICAL CO., LTD. CN 317 024 Linhai	R1-CEP 2010-208-Rev 00	05/12/2016	VALID	/	Chemistry
Lamotrigine	Union Quimico Farmaceutica, S.A. (Uquifa S.A.) ES 08008 Barcelona	R1-CEP 2010-382-Rev 02	28/05/2021	VALID	/	Chemistry
Lamotrigine	TEVA PHARMACEUTICAL INDUSTRIES LTD. IL 4951033 Petach Tikva	R1-CEP 2011-178-Rev 01	20/05/2021	VALID	/	Chemistry

Producer:Zhejiang Huahai Pharmaceutical Co., Ltd.was founded in 1989 and headquartered in Zhejiang, China. The company has nearly 7000 employees and more than 40 subsidiaries around the world (including China, the United States, Japan, Germany, etc.As a leading enterprise in the internationalization of Chinese medicine, Huahai pharmaceutical is the first pharmaceutical company in China to pass the FDA preparation quality certification and independently own the Anda document number. It is also the first Chinese pharmaceutical company to realize large-scale preparation sales in the United States. It has established China's pharmaceutical quality image in the world's high-end pharmaceutical market.

Staff size:About 7000 persons

Registered capital:RMB 1 billion 492 million

Producer:Sanjin Group Hunan Sanjin Pharmaceutical Co., Ltd. is a key investment attraction enterprise of Changde Municipal Government in 2003. It is a modern enterprise controlled by Sanjin group integrating scientific research, production and sales. The company is located in the high tech Industrial Park of Deshan Development Zone, Changde City, with a registered capital of 30 million yuan. As the largest inter provincial investment project of Sanjin group, Hunan Sanjin covers an area of more than 200 mu and has Chinese and Western medicine preparation production lines and herbal tea beverage production lines. Among them, tablet, granule, capsule and chemical synthetic API production lines have passed the national GMP certification and obtained the drug GMP certificate issued by the State Drug and food administration, Beverage products have obtained the national QS production license.

Staff size:200-299 persons

Registered capital:RMB 160 million

For supply and market information, please feel free to contact Mr. Paul, paulzhang@yinuopharmchem.com, WhatsApp: +86 18402846978