Tacrolimus

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ACTIVE PHARMA INGREDIENTS

79 API Suppliers, 31 USDMF, 12 CEP/COS, 7 JDMF, 8 EU WC, 15 KDMF, 27 NDC API, 36 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

93 Drugs in Development

93 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

746 FDF Dossiers, 63 FDA Orange Book, 445 Europe, 19 Canada, 96 Australia, 35 South Africa, 88 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 0.75MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 1MG BASE, TABLET, EXTENDED RELEASE;ORAL - EQ 4MG BASE, CAPSULE;ORAL - EQ 0.5MG BASE, CAPSULE;ORAL - EQ 1MG BASE, CAPSULE;ORAL - EQ 5MG BASE

RELATED EXCIPIENT COMPANIES

2 SPI Pharma, 12 DKSH, 3 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Capital Farma, 1 Kirsch Pharma, 4 ACG Worldwide, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 7 BASF, 11 Corel Pharma Chem, 4 DFE Pharma, 1 Finar, 4 Gangwal Chemicals, 3 Ideal Cures, 1 Ingredion Pharma Solutions, 22 Kerry, 1 Keval Exports, 3 Kima Chemical, 6 Lonza Capsugel, 9 Microlex e.U, 1 Nanjing Bold Chemical, 1 Nitika Pharmaceutical Specialities, 1 Novo Excipients, 4 Pluviaendo, 2 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 3 Roquette, 7 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 3 Sigachi Industries, 2 Silverline Chemicals, 2 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

41 Coating Systems & Additives, 23 Fillers, Diluents & Binders, 18 Granulation, 17 Direct Compression, 13 Lubricants & Glidants, 12 Thickeners and Stabilizers, 12 Controlled & Modified Release, 10 Film Formers & Plasticizers, 10 Disintegrants & Superdisintegrants, 9 Empty Capsules, 9 Solubilizers, 8 Topical, 7 Emulsifying Agents, 5 Rheology Modifiers, 5 Taste Masking, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 3 Parenteral, 3 Co-Processed Excipients, 2 Surfactant & Foaming Agents, 1 Chewable & Orodispersible Aids

DIGITAL CONTENT

62 News #PharmaBuzz

62 News #PharmaBuzz

GLOBAL SALES INFORMATION

25 US Medicaid Prescriptions, 111 Regulatory FDF Prices, 12 Annual Reports

MARKET PLACE

47 APIs, 14 FDF Dossiers

PATENTS & EXCLUSIVITIES

45 US Patents, 15 US Exclusivities, 29 Health Canada Patents

REF. STANDARDS & IMPURITIES

2 USP, 1 JP, 7 Others

ANALYTICAL

1 BioAnalytical Methods, 4 Analytical Methods

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USFDA APPLICATION NUMBER - 206406 / DOSAGE - TABLET, EXTENDED RELEASE;ORAL - EQ 0.75MG BASE

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TACROLIMUS(UNII: WM0HAQ4WNM) (TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J)	TACROLIMUS ANHYDROUS	0.75mg \| 1mg \| 4mg

Inactive Ingredients

Ingredient Name	Carton Service, Incorporated
BUTYLATED HYDROXYTOLUENE(1P9D0Z171K)
DIMETHICONE(92RU3N3Y1O)
HYPROMELLOSES(3NXW29V3WO)
LACTOSE MONOHYDRATE(EWQ57Q8I5X)
MAGNESIUM STEARATE(70097M6I30)
POLOXAMER 188(LQA7B6G8JG)
POLYETHYLENE GLYCOL 6000(30IQX730WE)
TARTARIC ACID(W4888I119H)

Setid 5beb0a8a 0c8c 5813 E053 2991aa0a8b30 Applno 206406 Form Tablet Extended Release Oral Dosage Eq 0 75mg Base - Drug Product Composition: Tacrolimus

Tacrolimus

Tacrolimus

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

79 API Suppliers

31 USDMF

12 CEP/COS

7 JDMF

8 EU WC

15 KDMF

27 NDC API

36 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

93 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

746 FDF Dossiers

63 FDA Orange Book

445 Europe

19 Canada

96 Australia

35 South Africa

88 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET, EXTENDED RELEASE;ORAL - EQ 0.75MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 1MG BASE

TABLET, EXTENDED RELEASE;ORAL - EQ 4MG BASE

CAPSULE;ORAL - EQ 0.5MG BASE

CAPSULE;ORAL - EQ 1MG BASE

CAPSULE;ORAL - EQ 5MG BASE

RELATED EXCIPIENT COMPANIES

2 SPI Pharma

12 DKSH

3 Gangwal Healthcare

5 Nanjing Well Pharmaceutical

1 Capital Farma

1 Kirsch Pharma

4 ACG Worldwide

5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

7 BASF

11 Corel Pharma Chem

4 DFE Pharma

1 Finar

4 Gangwal Chemicals

3 Ideal Cures

1 Ingredion Pharma Solutions

22 Kerry

1 Keval Exports

3 Kima Chemical

6 Lonza Capsugel

9 Microlex e.U

1 Nanjing Bold Chemical

1 Nitika Pharmaceutical Specialities

1 Novo Excipients

4 Pluviaendo

2 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

2 Qualicaps

3 Roquette

7 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

3 Sigachi Industries

2 Silverline Chemicals

2 The Dow Chemical Company

1 Valens Pharmachem

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

41 Coating Systems & Additives

23 Fillers, Diluents & Binders

18 Granulation

17 Direct Compression

13 Lubricants & Glidants

12 Thickeners and Stabilizers

12 Controlled & Modified Release