Repaglinide

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ACTIVE PHARMA INGREDIENTS

26 API Suppliers, 12 USDMF, 11 CEP/COS, 3 JDMF, 8 EU WC, 2 KDMF, 8 NDC API, 16 Listed Suppliers, $ API Reference Price

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

267 FDF Dossiers, 31 FDA Orange Book, 191 Europe, 18 Canada, 6 South Africa, 21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 500MG;1MG, TABLET;ORAL - 500MG;2MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 6 SPI Pharma, 2 Seqens, 3 DKSH, 1 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 12 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 5 Actylis, 1 Aeon Procare, 7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 27 BASF, 1 Corel Pharma Chem, 3 DFE Pharma, 1 Doshion Polyscience, 2 Finar, 9 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 5 Kerry, 8 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 6 Pluviaendo, 3 Prachin Chemical, 25 Roquette, 1 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 2 Ulanqab Kema New Material, 2 Valens Pharmachem, 3 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

50 Fillers, Diluents & Binders, 31 Direct Compression, 23 Disintegrants & Superdisintegrants, 21 Thickeners and Stabilizers, 20 Granulation, 20 Solubilizers, 17 Lubricants & Glidants, 16 Film Formers & Plasticizers, 15 Coating Systems & Additives, 15 Co-Processed Excipients, 15 Taste Masking, 15 Topical, 15 Controlled & Modified Release, 12 Parenteral, 8 Chewable & Orodispersible Aids, 5 Emulsifying Agents, 2 API Stability Enhancers, 2 Coloring Agents, 2 Rheology Modifiers, 1 Soft Gelatin, 1 Surfactant & Foaming Agents

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GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 155 Finished Drug Prices, 5 Annual Reports

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7 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

6 Health Canada Patents

6 Health Canada Patents

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 5 Others

ANALYTICAL

1 BioAnalytical Methods

1 BioAnalytical Methods

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USFDA APPLICATION NUMBER - 20741 / DOSAGE - TABLET;ORAL - 1MG **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
REPAGLINIDE(UNII: 668Z8C33LU) (REPAGLINIDE - UNII:668Z8C33LU)	REPAGLINIDE	0.5mg

Inactive Ingredients

Ingredient Name	Cardinal Health	Lake Erie Medical DBA Quality Care Products LLC
1,2-DIMYRISTOYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL))(2847IF81RI)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE(L11K75P92J)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS(L11K75P92J)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
FERRIC OXIDE RED(1K09F3G675)
GLYCEROL FORMAL(3L7GR2604E)
MAGNESIUM STEARATE(70097M6I30)
MEGLUMINE(6HG8UB2MUY)
POLACRILIN POTASSIUM(0BZ5A00FQU)
POLOXAMER 124(1S66E28KXA)
POVIDONE(FZ989GH94E)
POVIDONES(FZ989GH94E)
STARCH, CORN(O8232NY3SJ)

Drug Product Composition: Repaglinide

Repaglinide

Repaglinide

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

26 API Suppliers

12 USDMF

11 CEP/COS

3 JDMF

8 EU WC

2 KDMF

8 NDC API

16 Listed Suppliers

$ API Reference Price

INTERMEDIATES

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

267 FDF Dossiers

31 FDA Orange Book

191 Europe

18 Canada

6 South Africa

21 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 1MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 2MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 500MG;1MG

TABLET;ORAL - 500MG;2MG

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

6 SPI Pharma

2 Seqens

3 DKSH

1 Jai Radhe Sales

4 Boai NKY Pharmaceuticals Ltd

12 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

5 Actylis

1 Aeon Procare

7 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

27 BASF

1 Corel Pharma Chem

3 DFE Pharma

1 Doshion Polyscience

2 Finar

9 Gangwal Chemicals

1 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

5 Kerry

8 Microlex e.U

2 Nanjing Bold Chemical

2 Nomisma Healthcare

1 Novo Excipients

2 Pharmatrans-Sanaq

6 Pluviaendo

3 Prachin Chemical

25 Roquette

1 Seppic

6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

10 Sigachi Industries

2 Ulanqab Kema New Material

2 Valens Pharmachem

3 Vasa Pharmachem

1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

50 Fillers, Diluents & Binders

31 Direct Compression

23 Disintegrants & Superdisintegrants

21 Thickeners and Stabilizers

20 Granulation

20 Solubilizers

17 Lubricants & Glidants

16 Film Formers & Plasticizers

15 Coating Systems & Additives

TABLET;ORAL - 0.5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 1MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 2MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons