Lamotrigine

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ACTIVE PHARMA INGREDIENTS

64 API Suppliers, 34 USDMF, 22 CEP/COS, 5 JDMF, 21 EU WC, 9 KDMF, 20 NDC API, 37 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 Drugs in Development

INTERMEDIATES

21 Intermediates Suppliers

21 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1077 FDF Dossiers, 230 FDA Orange Book, 597 Europe, 38 Canada, 66 Australia, 76 South Africa, 70 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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- 150MG, TABLET;ORAL - 200MG, TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 25MG, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Minakem, 3 Evonik, 5 Rochem International Inc, 22 SPI Pharma, 2 Seqens, 6 DKSH, 1 Pharm-RX Chemical, 8 Faran Shimi Pharmaceutical, 10 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 16 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 8 Actylis, 3 Aeon Procare, 4 Alcedo Pharmachem, 11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 38 BASF, 1 Bioplus Life Sciences, 1 Clariant, 16 Corel Pharma Chem, 7 DFE Pharma, 4 Doshion Polyscience, 1 Finar, 13 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 12 Ideal Cures Pvt Ltd, 5 Ingredion Pharma Solutions, 40 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 20 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 5 Novo Excipients, 5 Pharmatrans-Sanaq, 9 Pluviaendo, 5 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 23 Roquette, 14 Seppic, 9 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 2 The Dow Chemical Company, 2 Ulanqab Kema New Material, 3 Valens Pharmachem, 5 Vasa Pharmachem, 1 Vertellus

EXCIPIENTS BY APPLICATIONS

105 Fillers, Diluents & Binders, 77 Coating Systems & Additives, 57 Direct Compression, 49 Disintegrants & Superdisintegrants, 45 Controlled & Modified Release, 39 Taste Masking, 34 Granulation, 31 Solubilizers, 28 Thickeners and Stabilizers, 27 Lubricants & Glidants, 24 Co-Processed Excipients, 22 Chewable & Orodispersible Aids, 22 Film Formers & Plasticizers, 19 Parenteral, 15 Topical, 8 API Stability Enhancers, 7 Emulsifying Agents, 5 Rheology Modifiers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

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ANALYTICAL

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1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 20241 / DOSAGE - TABLET;ORAL - 250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
LAMOTRIGINE(UNII: U3H27498KS) (LAMOTRIGINE - UNII:U3H27498KS)	LAMOTRIGINE	100mg

Inactive Ingredients

Ingredient Name	Lake Erie Medical & Surgical Supply DBA Quality Care Products LLC	PD-Rx Pharmaceuticals, Inc.	REMEDYREPACK INC.
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FD&C BLUE NO. 2(L06K8R7DQK)
FD&C YELLOW NO. 6(H77VEI93A8)
FERRIC OXIDE YELLOW(EX438O2MRT)
LACTOSE(J2B2A4N98G)
LACTOSE, UNSPECIFIED FORM(J2B2A4N98G)
MAGNESIUM STEARATE(70097M6I30)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POVIDONE(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
SODIUM STARCH GLYCOLATE TYPE A POTATO(5856J3G2A2)

Drug Product Composition: Lamotrigine

Lamotrigine

Lamotrigine

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

64 API Suppliers

34 USDMF

22 CEP/COS

5 JDMF

21 EU WC

9 KDMF

20 NDC API

37 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

INTERMEDIATES

21 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

1077 FDF Dossiers

230 FDA Orange Book

597 Europe

38 Canada

66 Australia

76 South Africa

70 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

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**

RELATED EXCIPIENT COMPANIES

1 Minakem

3 Evonik

5 Rochem International Inc

22 SPI Pharma

2 Seqens

6 DKSH

1 Pharm-RX Chemical

8 Faran Shimi Pharmaceutical

10 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

16 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 ACG Worldwide

8 Actylis

3 Aeon Procare

4 Alcedo Pharmachem

11 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

38 BASF

1 Bioplus Life Sciences

1 Clariant

16 Corel Pharma Chem

7 DFE Pharma

4 Doshion Polyscience

1 Finar

13 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

12 Ideal Cures Pvt Ltd

5 Ingredion Pharma Solutions

40 Kerry

3 Kima Chemical

6 Lonza Capsugel

20 Microlex e.U

1 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

5 Novo Excipients

5 Pharmatrans-Sanaq

9 Pluviaendo

5 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

23 Roquette

TABLET;ORAL - 250MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons