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Approved Drug Products containing Ambap5429 listed in the FDA Orange Book. Original Data : FDA Website

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Product

Ambap5429
FDA Orange Book

PharmaCompass Sponsored Ads

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As a CDMO, Mikart offers integrated CDMO services for Solid Dose & Non-sterile Liquid formulations.

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xyz-pharma-m-2024-10-07

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PharmaCompass Sponsored Ads

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Gensenta is a trusted CDMO partner with robust history, commitment to quality, innovative mindset and commitment to sustainability.

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xyz-pharma-m-2024-10-07

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Ambap5429

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

57 API Suppliers, 29 USDMF, 10 CEP/COS, 8 JDMF, 3 EU WC, 13 KDMF, 24 NDC API, 32 Listed Suppliers, $ API Reference Price

57 API Suppliers
29 USDMF
10 CEP/COS
8 JDMF
3 EU WC
13 KDMF
24 NDC API
32 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

23 Drugs in Development

23 Drugs in Development

PRICE INFORMATION

API Reference Price, API Exports, API Imports, FDF Exports, FDF Imports

API Reference Price
API Exports
API Imports
FDF Exports
FDF Imports

INTERMEDIATES

2 API Suppliers

2 API Suppliers

FINISHED DOSAGE FORMULATIONS

493 FDF Dossiers, 62 FDA Orange Book, 206 Europe, 19 Canada, 96 Australia, 32 South Africa, 78 Listed Dossiers

493 FDF Dossiers
62 FDA Orange Book
206 Europe
19 Canada
96 Australia
32 South Africa
78 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, 9 DKSH, 1 Jai Radhe Sales, 5 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 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, 40 Fillers, Diluents & Binders, 18 Controlled & Modified Release, 16 Direct Compression, 13 Granulation, 13 Lubricants & Glidants, 11 Film Formers & Plasticizers, 10 Disintegrants & Superdisintegrants, 9 Empty Capsules, 9 Solubilizers, 9 Topical, 9 Thickeners and Stabilizers, 7 Co-Processed Excipients, 7 Emulsifying Agents, 5 Taste Masking, 5 Coloring Agents, 4 Vegetarian Capsules, 4 API Stability Enhancers, 4 Parenteral, 2 Rheology Modifiers, 1 Surfactant & Foaming Agents, 1 Chewable & Orodispersible Aids

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

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 55 NEWS #PharmaBuzz

4 DATA COMPILATION #PharmaFlow
55 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

3 US Medicaid Prescriptions, 137 Finished Drug Prices, 11 Annual Reports

3 US Medicaid Prescriptions
137 Finished Drug Prices
11 Annual Reports

MARKET PLACE

42 APIs, 14 FDF Dossiers

42 APIs
14 FDF Dossiers

PATENTS & EXCLUSIVITIES

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

84 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) : 68,727 Xls

Filters

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FILTER :

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62 All

01 3STRIDES PHARMA

02 5ACCORD HLTHCARE

03 3ALKEM LABS LTD

04 9ASTELLAS

05 3BELCHER

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 3PANACEA

19 3SANDOZ

20 3VELOXIS PHARMS INC

filter Dosage Reset all filters

62 All

01 6CAPSULE, EXTENDED RELEASE;ORAL

02 40CAPSULE;ORAL

03 2FOR SUSPENSION;ORAL

04 2INJECTABLE;INJECTION

05 9OINTMENT;TOPICAL

06 3TABLET, EXTENDED RELEASE;ORAL

filter Regulatory Info Reset all filters

62 All

01 3DISCN

02 59RX

filter Brand Name Reset all filters

62 All

01 3ASTAGRAF XL

02 3ENVARSUS XR

03 6PROGRAF

04 2PROTOPIC

05 48TACROLIMUS

filter RLD Reset all filters

62 All

01 48No

02 14Yes

FDF Dossiers
FDA Orange Book
Europe
Canada
Australia
South Africa
Listed Dossiers

List of Suppliers

Product Main Page

01

STRIDES PHARMA

CPhI Worldwide, Milan

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

Product Web Link

Digital Content

02

STRIDES PHARMA

CPhI Worldwide, Milan

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

Product Web Link

Digital Content

03

STRIDES PHARMA

CPhI Worldwide, Milan

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

Contact Supplier

Contact Supplier

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

Product Web Link

Digital Content

04

ASTELLAS

The Battery Show

Not Confirmed

ASTELLAS

The Battery Show

Not Confirmed

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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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

05

ASTELLAS

The Battery Show

Not Confirmed

ASTELLAS

The Battery Show

Not Confirmed

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Digital Content

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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

06

ASTELLAS

The Battery Show

Not Confirmed

ASTELLAS

The Battery Show

Not Confirmed

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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

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

ASTELLAS

The Battery Show

Not Confirmed

ASTELLAS

The Battery Show

Not Confirmed

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Digital Content

RLD : Yes

TE Code :

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 :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

LEO PHARMA AS

The Battery Show

Not Confirmed

LEO PHARMA AS

The Battery Show

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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

Product Web Link

Digital Content

Corporate PDF

09

LEO PHARMA AS

The Battery Show

Not Confirmed

LEO PHARMA AS

The Battery Show

Not Confirmed

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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

Product Web Link

Digital Content

Corporate PDF

10

SANDOZ

The Battery Show

Not Confirmed

SANDOZ

The Battery Show

Not Confirmed

Boost your online visibility by uploading your products, APIs, FDFs, intermediates, excipients, and services for free on PharmaCompass. Rank higher among suppliers and expand your reach across the internet efficiently and cost-effectively.

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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

Product Web Link

Digital Content

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