Sirolimus

ACCESS ALL DATA, CHEMISTRY

ACTIVE PHARMA INGREDIENTS

53 API Suppliers, 30 USDMF, 4 JDMF, 2 EU WC, 4 KDMF, 17 NDC API, 31 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

78 Drugs in Development

78 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

105 FDF Dossiers, 24 FDA Orange Book, 17 Europe, 2 Canada, 16 Australia, 31 South Africa, 15 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- 1MG, TABLET;ORAL - 2MG, TABLET;ORAL - 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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, 14 SPI Pharma, 2 Seqens, 2 DKSH, 4 Faran Shimi Pharmaceutical, 8 Boai NKY Pharmaceuticals Ltd, 4 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

69 Fillers, Diluents & Binders, 47 Coating Systems & Additives, 31 Direct Compression, 29 Controlled & Modified Release, 28 Solubilizers, 25 Granulation, 24 Thickeners and Stabilizers, 21 Disintegrants & Superdisintegrants, 17 Parenteral, 16 Co-Processed Excipients, 16 Taste Masking, 15 Chewable & Orodispersible Aids, 15 Film Formers & Plasticizers, 14 Topical, 12 Lubricants & Glidants, 7 Emulsifying Agents, 5 Empty Capsules, 5 API Stability Enhancers, 4 Vegetarian Capsules, 4 Coloring Agents, 3 Rheology Modifiers, 2 Surfactant & Foaming Agents

DIGITAL CONTENT

1 DATA COMPILATION #PharmaFlow, 61 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

MARKET PLACE

22 APIs, 4 FDF Dossiers

PATENTS & EXCLUSIVITIES

9 US Patents, 4 US Exclusivities, 17 Health Canada Patents

REF. STANDARDS & IMPURITIES

1 Others

1 Others

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USFDA APPLICATION NUMBER - 21110 / DOSAGE - TABLET;ORAL - 1MG

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
sirolimus(UNII: W36ZG6FT64) (sirolimus - UNII:W36ZG6FT64)	sirolimus	1mg

Inactive Ingredients

Ingredient Name	American Health Packaging	Cardinal Health	Dr. Reddy's Laboratories Limited
.ALPHA.-TOCOPHEROL ACETATE(9E8X80D2L0)
1-GLYCERYL MONOOLEATE(D3AEF6S35P)
alpha-tocopherol(H4N855PNZ1)
ammonia(5138Q19F1X)
calcium sulfate(WAT0DDB505)
carnauba wax(R12CBM0EIZ)
cellulose, microcrystalline(OP1R32D61U)
CITRIC ACID MONOHYDRATE(2968PHW8QP)
CROSPOVIDONE, UNSPECIFIED(2S7830E561)
ethylcelluloses(7Z8S9VYZ4B)
FD&C Red No. 40(WZB9127XOA)
FD&C YELLOW NO. 5(I753WB2F1M)
ferric oxide red(1K09F3G675)
FERRIC OXIDE YELLOW(EX438O2MRT)
GLYCERYL MONOOLEATE(C4YAD5F5G6)
hypromellose 2910 (5 MPA.S)(R75537T0T4)
HYPROMELLOSE, UNSPECIFIED(3NXW29V3WO)
lactose monohydrate(EWQ57Q8I5X)
lactose(J2B2A4N98G)
magnesium stearate(70097M6I30)
mannitol(3OWL53L36A)
MICROCRYSTALLINE CELLULOSE(OP1R32D61U)
POLOXAMER 188(LQA7B6G8JG)
POLYETHYLENE GLYCOL 8000(Q662QK8M3B)
POLYETHYLENE GLYCOL(3WJQ0SDW1A)
Polyethylene Glycol, Unspecified(3WJQ0SDW1A)
povidone(FZ989GH94E)
POVIDONE, UNSPECIFIED(FZ989GH94E)
propylene glycol(6DC9Q167V3)
shellac(46N107B71O)
sucrose(C151H8M554)
TALC(7SEV7J4R1U)
titanium dioxide(15FIX9V2JP)

Drug Product Composition: Sirolimus

Sirolimus

Sirolimus

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CHEMISTRY

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ACTIVE PHARMA INGREDIENTS

53 API Suppliers

30 USDMF

4 JDMF

2 EU WC

4 KDMF

17 NDC API

31 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

78 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

105 FDF Dossiers

24 FDA Orange Book

17 Europe

2 Canada

16 Australia

31 South Africa

15 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

14 SPI Pharma

2 Seqens

2 DKSH

4 Faran Shimi Pharmaceutical

8 Boai NKY Pharmaceuticals Ltd

4 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

69 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