Sirolimus

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ACTIVE PHARMA INGREDIENTS

50 API Suppliers, 30 USDMF, 4 JDMF, 2 EU WC, 4 KDMF, 16 NDC API, 28 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

71 Drugs in Development

71 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

101 FDF Dossiers, 24 FDA Orange Book, 17 Europe, 2 Canada, 16 Australia, 31 South Africa, 11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.5MG, TABLET;ORAL - 1MG, TABLET;ORAL - 2MG, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc, 13 SPI Pharma, 2 Seqens, 2 DKSH, 4 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 9 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 25 BASF, 11 Corel Pharma Chem, 4 DFE Pharma, 2 Finar, 10 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 31 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 14 Microlex e.U, 2 Nanjing Bold Chemical, 2 Nomisma Healthcare, 3 Novo Excipients, 3 Pharmatrans-Sanaq, 4 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 13 Roquette, 13 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 3 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

73 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 38 Direct Compression, 30 Controlled & Modified Release, 27 Solubilizers, 25 Granulation, 25 Thickeners and Stabilizers, 20 Co-Processed Excipients, 18 Disintegrants & Superdisintegrants, 17 Parenteral, 15 Taste Masking, 15 Film Formers & Plasticizers, 14 Topical, 14 Chewable & Orodispersible Aids, 13 Lubricants & Glidants, 7 Emulsifying Agents, 6 API Stability Enhancers, 5 Empty Capsules, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Rheology Modifiers, 2 Surfactant & Foaming Agents

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3 US Medicaid Prescriptions, 18 Finished Drug Prices, 3 Annual Reports

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USFDA APPLICATION NUMBER - 21110 / DOSAGE - TABLET;ORAL - 5MG **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
sirolimus(UNII: W36ZG6FT64) (sirolimus - UNII:W36ZG6FT64)	sirolimus	1mg

Inactive Ingredients

Ingredient Name	Cardinal Health
1-GLYCERYL MONOOLEATE(D3AEF6S35P)
ALPHA-TOCOPHEROL(H4N855PNZ1)
calcium sulfate(WAT0DDB505)
CARNAUBA WAX(R12CBM0EIZ)
CELLULOSE, MICROCRYSTALLINE(OP1R32D61U)
lactose(J2B2A4N98G)
magnesium stearate(70097M6I30)
POLOXAMER 188(LQA7B6G8JG)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
povidone(FZ989GH94E)
SHELLAC(46N107B71O)
sucrose(C151H8M554)
talc(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)

Drug Product Composition: Sirolimus

Sirolimus

Sirolimus

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

50 API Suppliers

30 USDMF

4 JDMF

2 EU WC

4 KDMF

16 NDC API

28 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

71 Drugs in Development

INTERMEDIATES

3 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

101 FDF Dossiers

24 FDA Orange Book

17 Europe

2 Canada

16 Australia

31 South Africa

11 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 0.5MG

TABLET;ORAL - 1MG

TABLET;ORAL - 2MG

TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RELATED EXCIPIENT COMPANIES

1 Rochem International Inc

13 SPI Pharma

2 Seqens

2 DKSH

4 Faran Shimi Pharmaceutical

8 Boai NKY Pharmaceuticals Ltd

9 Gangwal Healthcare

4 Nanjing Well Pharmaceutical

2 Pfanstiehl

1 ACG Worldwide

6 Actylis

1 Aeon Procare

1 Alcedo Pharmachem

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

25 BASF

11 Corel Pharma Chem

4 DFE Pharma

2 Finar

10 Gangwal Chemicals

5 Ideal Cures Pvt Ltd

1 Ingredion Pharma Solutions

31 Kerry

4 Kima Chemical

6 Lonza Capsugel

14 Microlex e.U

2 Nanjing Bold Chemical

2 Nomisma Healthcare

3 Novo Excipients

3 Pharmatrans-Sanaq

4 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

13 Roquette

13 Seppic

5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

1 Shanghai Welltone Material Technology Co., Ltd

1 Shijiazhuang Huaxu Pharmaceutical

10 Sigachi Industries

3 The Dow Chemical Company

2 Ulanqab Kema New Material

1 Valens Pharmachem

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

73 Fillers, Diluents & Binders

47 Coating Systems & Additives

TABLET;ORAL - 5MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons