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List of Drug Master Files (DMF) of Lamictal Active Pharmaceutical Ingredient (API) submitted to the U.S. FDA. Original Data : FDA Website

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01 IOL Chemicals and Pharmaceuticals (2)

02 Polpharma (1)

03 Taro Pharmaceutical Industries (1)

04 Medichem S.A (1)

05 Adare Pharma Solutions (1)

06 Alembic Pharmaceuticals Limited (1)

07 Alkem Laboratories (1)

08 Apotex Pharmachem (1)

09 Aragen Life Sciences (1)

10 Aurobindo Pharma Limited (1)

11 CTX Lifesciences (1)

12 Cambrex Corporation (1)

13 Cipla (1)

14 Gedeon Richter (1)

15 Jubilant Generics (1)

16 Lupin Ltd (1)

17 RA CHEM PHARMA LIMITED (1)

18 SEQUEL PHARMACHEM PRIVATE LTD. IN 400 706 Nerul (1)

19 SMS Pharmaceuticals (1)

20 Sun Pharmaceutical Industries Limited (1)

21 Suven Life Sciences Limited (1)

22 Syn-Tech Chem. & Pharm (1)

23 Synthexim (1)

24 Teva API (1)

25 Torrent Pharmaceuticals Limited (1)

26 UQUIFA (1)

27 Unichem Laboratories Limited (1)

28 Unimark Remedies Limited (1)

29 Viatris (1)

30 Waterstone Pharmaceuticals Inc. (1)

31 Zhejiang Huahai Pharmaceutical (1)

32 Zhejiang Supor Pharmaceuticals Co., LTD (1)

33 Zydus Lifesciences (1)

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01 EUR-1048 ORALLY DISINTEGRATING TABLETS (1)

02 LAMOTRIGINE (9)

03 LAMOTRIGINE DRUG SUBSTANCE (1)

04 LAMOTRIGINE EP (1)

05 LAMOTRIGINE USP (16)

06 LAMOTRIGINE USP (MICRONISED) (1)

07 LAMOTRIGINE USP (NON-STERILE DRUG SUBSTANCE) (1)

08 LAMOTRIGINE USP API (1)

09 LAMOTRIGINE, USP, NON-STERILE DRUG SUBSTANCE (1)

10 LAMOTRINGINE (1)

11 Lamotrigine (1)

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01 Canada (1)

02 China (3)

03 France (1)

04 Hungary (1)

05 India (19)

06 Israel (1)

07 Poland (1)

08 Spain (2)

09 Taiwan (1)

10 U.S.A (4)

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01 Active (25)

02 Inactive (9)

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01 Complete (14)

02 Blank (20)

URL Supplier Web Content
NA Not Available For Sales
18960
Active
2005-11-17
Complete
2024-04-07
2024-04-03
II
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16142
Active
2002-09-24
Complete
2014-05-16
2014-05-13
II
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16259
Active
2002-11-20
Complete
2013-10-05
2013-09-26
II
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15924
Active
2002-04-04
Complete
2012-11-30
2012-11-09
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17740
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2004-10-08
N/A
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18090
Active
2005-02-17
Complete
2014-04-28
2014-04-21
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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 USDMF

A Lamictal DMF (Drug Master File) is a document detailing the whole manufacturing process of Lamictal active pharmaceutical ingredient (API) in detail. Different forms of Lamictal DMFs exist exist since differing nations have different regulations, such as Lamictal USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Lamictal DMF submitted to regulatory agencies in the US is known as a USDMF. Lamictal USDMF includes data on Lamictal's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lamictal USDMF is kept confidential to protect the manufacturer’s intellectual property.

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

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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