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List of Korea Drug Master Files (KDMF) for Lamictal Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Wooshin Rabotachi Co., Ltd.
2021-11-01
20210611-209-J-1025(1)
Pharmaceutical Works Polp...
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19, Pelplinska street, 83...
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Hallym Pharmaceutical Co., Ltd.
2021-06-11
20210611-209-J-1025
Pharmaceutical Works Polp...
Poland
19, Pelplinska Street., 8...
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Samo Pharmaceutical Co., Ltd.
2021-10-05
20211005-209-J-1000
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Seongui Bio Co., Ltd.
2021-07-26
20210726-209-J-1078
Apitoria Pharma Private L...
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Wonpoong Pharmaceutical Co., Ltd.
2022-12-12
20220112-209-J-1158(A)
Cohance Lifescience Limit...
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API Unit-I, RS 50/1, Mukt...
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Masung LS Co., Ltd.
2022-01-12
20220112-209-J-1158
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RS 50/1,Mukteswarapuram V...
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GlaxoSmithKline Co., Ltd.
2021-05-03
20210503-209-J-966
Divi's Laboratories Limit...
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Unit-2, Chippada Village,...
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Wonpoong Pharmaceutical Co., Ltd.
2022-09-06
20220906-209-J-1357
Zhejiang Supor Pharmaceut...
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Yuedong Road, Paojiang In...
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Leeyeon Pharmaceutical Co., Ltd.
2022-01-10
20220110-209-J-1204
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69-10 Hansam-ro, Deoksan-...
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  • TABLET;ORAL - 100MG
  • TABLET;ORAL - 150MG
  • TABLET;ORAL - 200MG
  • TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 25MG
  • TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 84057-84-1 / Lamotrigine API manufacturers, exporters & distributors?

Lamotrigine manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Lamotrigine API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Lamotrigine manufacturer or Lamotrigine supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Lamotrigine manufacturer or Lamotrigine supplier.

PharmaCompass also assists you with knowing the Lamotrigine API Price utilized in the formulation of products. Lamotrigine API Price is not always fixed or binding as the Lamotrigine Price is obtained through a variety of data sources. The Lamotrigine Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Lamotrigine

Synonyms

84057-84-1, 6-(2,3-dichlorophenyl)-1,2,4-triazine-3,5-diamine, Lamictal, Lamictal cd, Lamictal xr, Lamotrigina

Cas Number

84057-84-1

Unique Ingredient Identifier (UNII)

U3H27498KS

About Lamotrigine

A phenyltriazine compound, sodium and calcium channel blocker that is used for the treatment of SEIZURES and BIPOLAR DISORDER.

Lamictal Manufacturers

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.

Lamictal Suppliers

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.

Lamictal KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Lamictal Drug Master File in Korea (Lamictal KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lamictal. The MFDS reviews the Lamictal KDMF as part of the drug registration process and uses the information provided in the Lamictal KDMF to evaluate the safety and efficacy of the drug.

After submitting a Lamictal KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Lamictal API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Lamictal suppliers with KDMF on PharmaCompass.

Lamictal Manufacturers | Traders | Suppliers

Lamictal Manufacturers, Traders, Suppliers 1
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We have 6 companies offering Lamictal

Get in contact with the supplier of your choice:

  1. Polpharma
  2. Assia Chemical Industries Ltd
  3. Aurobindo Pharma Limited
  4. Cohance Lifesciences
  5. Divis Laboratories
  6. Zhejiang Supor Pharmaceuticals Co., LTD
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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