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Tacrolimus Monohydrate
FDA Orange Book

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Tacrolimus Monohydrate

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
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ACTIVE PHARMA INGREDIENTS

55 API Suppliers, 30 USDMF, 11 CEP/COS, 6 JDMF, 4 EU WC, 13 KDMF, 25 NDC API, 31 Listed Suppliers, $ API Reference Price

55 API Suppliers
30 USDMF
11 CEP/COS
6 JDMF
4 EU WC
13 KDMF
25 NDC API
31 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

24 Drugs in Development

24 Drugs in Development

INTERMEDIATES

3 Intermediate Suppliers

3 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

485 FDF Dossiers, 63 FDA Orange Book, 206 Europe, 19 Canada, 96 Australia, 20 South Africa, 81 Listed Dossiers

485 FDF Dossiers
63 FDA Orange Book
206 Europe
19 Canada
96 Australia
20 South Africa
81 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

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, 11 DKSH, 4 Faran Shimi Pharmaceutical, 3 Gangwal Healthcare, 5 Nanjing Well Pharmaceutical, 1 Capital Farma, 4 ACG Worldwide, 5 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 7 BASF, 11 Corel Pharma Chem, 4 DFE Pharma, 1 Finar, 4 Gangwal Chemicals, 4 Ideal Cures Pvt Ltd, 1 Ingredion Pharma Solutions, 33 Kerry, 3 Kima Chemical, 6 Lonza Capsugel, 9 Microlex e.U, 1 Nanjing Bold Chemical, 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, 4 Sigachi Industries, 2 The Dow Chemical Company, 1 Valens Pharmachem, 2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

45 Coating Systems & Additives, 38 Fillers, Diluents & Binders, 17 Controlled & Modified Release, 13 Lubricants & Glidants, 13 Granulation, 12 Direct Compression, 11 Thickeners and Stabilizers, 11 Film Formers & Plasticizers, 10 Disintegrants & Superdisintegrants, 9 Empty Capsules, 9 Solubilizers, 8 Topical, 7 Emulsifying Agents, 5 Co-Processed Excipients, 5 Taste Masking, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Rheology Modifiers, 3 Parenteral, 1 Chewable & Orodispersible Aids, 1 Surfactant & Foaming Agents

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

DIGITAL CONTENT

58 NEWS #PharmaBuzz

58 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 137 Regulatory FDF Prices, 11 Annual Reports

3 US Medicaid Prescriptions
137 Regulatory FDF Prices
11 Annual Reports

MARKET PLACE

45 APIs, 14 FDF Dossiers

45 APIs
14 FDF Dossiers

PATENTS & EXCLUSIVITIES

42 US Patents, 15 US Exclusivities, 19 Health Canada Patents

42 US Patents
15 US Exclusivities
19 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 USP, 1 JP, 10 Others

5 USP
1 JP
10 Others

ANALYTICAL

1 BioAnalytical Methods, 4 Analytical Methods

1 BioAnalytical Methods
4 Analytical Methods

$ API Ref.Price (USD/KG) : 68,468 Xls

Filters

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63 All

01 3STRIDES PHARMA

02 5ACCORD HLTHCARE

03 3AJENAT PHARMS

04 3ALKEM LABS LTD

05 9ASTELLAS

06 3BIOCON PHARMA

07 3CHENGDU

08 3CONCORD BIOTECH LTD

09 3DR REDDYS LABS LTD

10 1ENCUBE

11 2FOUGERA PHARMS INC

12 5GLENMARK PHARMS LTD

13 3HANGZHOU ZHONGMEI

14 1HERITAGE PHARMA AVET

15 1HOSPIRA

16 2LEO PHARMA AS

17 3MYLAN

18 1NEXUS

19 3PANACEA

20 3SANDOZ

21 3VELOXIS PHARMS INC

filter Dosage Reset all filters

63 All

01 6CAPSULE, EXTENDED RELEASE;ORAL

02 40CAPSULE;ORAL

03 2FOR SUSPENSION;ORAL

04 3INJECTABLE;INJECTION

05 9OINTMENT;TOPICAL

06 3TABLET, EXTENDED RELEASE;ORAL

filter Regulatory Info Reset all filters

63 All

01 2DISCN

02 61RX

filter Brand Name Reset all filters

63 All

01 3ASTAGRAF XL

02 3ENVARSUS XR

03 6PROGRAF

04 2PROTOPIC

05 49TACROLIMUS

filter RLD Reset all filters

63 All

01 49No

02 14Yes

Tacrolimus CCSB

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01

STRIDES PHARMA

Pharmagora Plus 2025

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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Digital Content

RLD : No

TE Code : AB

Brand Name : TACROLIMUS

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 0.5MG BASE

Approval Date : 2014-07-22

Application Number : 90687

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

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02

STRIDES PHARMA

Pharmagora Plus 2025

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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Digital Content

RLD : No

TE Code : AB

Brand Name : TACROLIMUS

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 1MG BASE

Approval Date : 2014-07-22

Application Number : 90687

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

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03

STRIDES PHARMA

Pharmagora Plus 2025

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Strides Pharma Science: Pioneering IP-driven formulations for niche finished dosage forms.

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Digital Content

RLD : No

TE Code : AB

Brand Name : TACROLIMUS

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 2014-07-22

Application Number : 90687

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

Strides Pharma Science

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Digital Content

04

ASTELLAS

Pharmagora Plus 2025

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ASTELLAS

Pharmagora Plus 2025

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Digital Content

RLD : Yes

TE Code : AB

Brand Name : PROGRAF

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 1MG BASE

Approval Date : 1994-04-08

Application Number : 50708

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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05

ASTELLAS

Pharmagora Plus 2025

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Pharmagora Plus 2025

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RLD : Yes

TE Code : AB

Brand Name : PROGRAF

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 5MG BASE

Approval Date : 1994-04-08

Application Number : 50708

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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Digital Content

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06

ASTELLAS

Pharmagora Plus 2025

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ASTELLAS

Pharmagora Plus 2025

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Digital Content

RLD : Yes

TE Code : AB

Brand Name : PROGRAF

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 0.5MG BASE

Approval Date : 1998-08-24

Application Number : 50708

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

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07

ASTELLAS

Pharmagora Plus 2025

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ASTELLAS

Pharmagora Plus 2025

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Digital Content

RLD : Yes

TE Code : AP

Brand Name : PROGRAF

Dosage Form : INJECTABLE;INJECTION

Dosage Strength : EQ 5MG BASE/ML

Approval Date : 1994-04-08

Application Number : 50709

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AP

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08

LEO PHARMA AS

Pharmagora Plus 2025

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LEO PHARMA AS

Pharmagora Plus 2025

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Digital Content

RLD : Yes

TE Code : AB

Brand Name : PROTOPIC

Dosage Form : OINTMENT;TOPICAL

Dosage Strength : 0.03%

Approval Date : 2000-12-08

Application Number : 50777

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

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Digital Content

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09

LEO PHARMA AS

Pharmagora Plus 2025

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LEO PHARMA AS

Pharmagora Plus 2025

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Digital Content

RLD : Yes

TE Code : AB

Brand Name : PROTOPIC

Dosage Form : OINTMENT;TOPICAL

Dosage Strength : 0.1%

Approval Date : 2000-12-08

Application Number : 50777

RX/OTC/DISCN : RX

RLD : Yes

TE Code : AB

Portfolio PDF

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Digital Content

Corporate PDF

10

SANDOZ

Pharmagora Plus 2025

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SANDOZ

Pharmagora Plus 2025

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Digital Content

RLD : No

TE Code : AB

Brand Name : TACROLIMUS

Dosage Form : CAPSULE;ORAL

Dosage Strength : EQ 0.5MG BASE

Approval Date : 2009-08-10

Application Number : 65461

RX/OTC/DISCN : RX

RLD : No

TE Code : AB

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