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Approved Drug Products containing Prestwick3_000429 listed in the FDA Orange Book. Original Data : FDA Website

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Product

Prestwick3_000429
FDA Orange Book

Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.

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Transo-Pharm GmbH works globally to supply Active Pharmaceutical Ingredients adhering to the highest quality & GMP standards.

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xyz-pharma-m-2024-09-09

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Metrochem has been delivering customized volume & quality products to customers across the world, taking utmost care of their needs.

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LGM Pharma accelerates & optimizes the new product pathway from early development through commercialization.

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xyz-pharma-m-2024-09-09

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Prestwick3_000429

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

42 API Suppliers, 20 USDMF, 13 CEP/COS, 2 JDMF, 2 EU WC, 3 NDC API, 19 Listed Suppliers, $ API Reference Price

42 API Suppliers
20 USDMF
13 CEP/COS
2 JDMF
2 EU WC
3 NDC API
19 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

4 Drugs in Development

4 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

FINISHED DOSAGE FORMULATIONS

691 FDF Dossiers, 6 FDA Orange Book, 412 Europe, 36 Canada, 6 South Africa, 231 Listed Dossiers

691 FDF Dossiers
6 FDA Orange Book
412 Europe
36 Canada
6 South Africa
231 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML, SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML, TABLET;ORAL - EQ 70MG BASE;2,800 IU, TABLET;ORAL - EQ 70MG BASE;5,600 IU

SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML
SOLUTION;INTRAVENOUS - 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML
TABLET;ORAL - EQ 70MG BASE;2,800 IU
TABLET;ORAL - EQ 70MG BASE;5,600 IU

RELATED EXCIPIENT COMPANIES

12 Rochem International Inc, 18 SPI Pharma, 2 Seqens, 15 DKSH, 2 Jai Radhe Sales, 2 Pharm-RX Chemical, 4 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 7 Nanjing Well Pharmaceutical, 2 Pfanstiehl, 4 ACG Worldwide, 11 Actylis, 1 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 32 BASF, 1 Bioplus Life Sciences, 1 Clariant, 11 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 11 Gangwal Chemicals, 5 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 33 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 19 Microlex e.U, 1 Nanjing Bold Chemical, 2 Nomisma Healthcare, 2 Novo Excipients, 2 Pharmatrans-Sanaq, 12 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 35 Roquette, 16 Seppic, 7 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 2 Shijiazhuang Huaxu Pharmaceutical, 11 Sigachi Industries, 4 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 3 Vasa Pharmachem, 2 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

105 Fillers, Diluents & Binders, 57 Coating Systems & Additives, 46 Thickeners and Stabilizers, 43 Direct Compression, 39 Taste Masking, 37 Solubilizers, 33 Controlled & Modified Release, 29 Granulation, 27 Parenteral, 26 Topical, 25 Film Formers & Plasticizers, 22 Disintegrants & Superdisintegrants, 21 Co-Processed Excipients, 19 Chewable & Orodispersible Aids, 19 Lubricants & Glidants, 13 Rheology Modifiers, 12 Emulsifying Agents, 9 Empty Capsules, 9 API Stability Enhancers, 6 Surfactant & Foaming Agents, 4 Vegetarian Capsules, 4 Coloring Agents, 1 Soft Gelatin

105 Fillers, Diluents & Binders
57 Coating Systems & Additives
46 Thickeners and Stabilizers
43 Direct Compression
39 Taste Masking
37 Solubilizers
33 Controlled & Modified Release
29 Granulation
27 Parenteral
26 Topical
25 Film Formers & Plasticizers
22 Disintegrants & Superdisintegrants
21 Co-Processed Excipients
19 Chewable & Orodispersible Aids
19 Lubricants & Glidants
13 Rheology Modifiers
12 Emulsifying Agents
9 Empty Capsules
9 API Stability Enhancers
6 Surfactant & Foaming Agents
4 Vegetarian Capsules
4 Coloring Agents
1 Soft Gelatin

DIGITAL CONTENT

2 DATA COMPILATION #PharmaFlow, 23 NEWS #PharmaBuzz

2 DATA COMPILATION #PharmaFlow
23 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

376 Finished Drug Prices, 5 Annual Reports

376 Finished Drug Prices
5 Annual Reports

MARKET PLACE

71 APIs, 23 FDF Dossiers

71 APIs
23 FDF Dossiers

REF. STANDARDS & IMPURITIES

3 EDQM, 1 USP, 1 JP, 3 Others

3 EDQM
1 USP
1 JP
3 Others

ANALYTICAL

3 Analytical Methods

3 Analytical Methods

$ API Ref.Price (USD/KG) : 370 Xls

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FILTER :

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6 All

01 2ORGANON LLC

02 4SANDOZ CANADA INC

filter Dosage Reset all filters

6 All

01 2INJECTABLE;INTRAVENOUS

02 2SOLUTION;INTRAVENOUS

03 2TABLET;ORAL

filter Regulatory Info Reset all filters

6 All

01 6RX

filter Brand Name Reset all filters

6 All

01 2FOSAMAX PLUS D

02 2INFUVITE ADULT

03 1INFUVITE PEDIATRIC

04 1INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)

filter RLD Reset all filters

6 All

01 6Yes

FDF Dossiers
FDA Orange Book
Europe
Canada
South Africa
Listed Dossiers

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01

ORGANON LLC

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ORGANON LLC

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RLD : Yes

TE Code :

ALENDRONATE SODIUM; CHOLECALCIFEROL

Brand Name : FOSAMAX PLUS D

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 70MG BASE;2,800 IU

Approval Date : 2005-04-07

Application Number : 21762

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

02

ORGANON LLC

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ORGANON LLC

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RLD : Yes

TE Code :

ALENDRONATE SODIUM; CHOLECALCIFEROL

Brand Name : FOSAMAX PLUS D

Dosage Form : TABLET;ORAL

Dosage Strength : EQ 70MG BASE;5,600 IU

Approval Date : 2007-04-26

Application Number : 21762

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

03

SANDOZ CANADA INC

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SANDOZ CANADA INC

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RLD : Yes

TE Code :

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K

Brand Name : INFUVITE ADULT

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;0.03MG/ML

Approval Date : 2000-05-18

Application Number : 21163

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product Web Link

Digital Content

04

SANDOZ CANADA INC

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SANDOZ CANADA INC

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Digital Content

RLD : Yes

TE Code :

ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K

Brand Name : INFUVITE ADULT

Dosage Form : SOLUTION;INTRAVENOUS

Dosage Strength : 2 IU/ML;40MG/ML;12MCG/ML;40 IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1.2MG/ML;0.72MG/ML;1.2MG/ML;660 IU/ML;30MCG/ML

Approval Date : 2003-06-16

Application Number : 21163

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product Web Link

Digital Content

05

SANDOZ CANADA INC

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SANDOZ CANADA INC

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Digital Content

RLD : Yes

TE Code :

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K

Brand Name : INFUVITE PEDIATRIC

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

Approval Date : 2001-02-21

Application Number : 21265

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product Web Link

Digital Content

06

SANDOZ CANADA INC

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Not Confirmed

SANDOZ CANADA INC

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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 : Yes

TE Code :

ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K

Brand Name : INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)

Dosage Form : INJECTABLE;INTRAVENOUS

Dosage Strength : 80MG/VIAL;0.02MG/VIAL;400 IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VIAL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL

Approval Date : 2004-01-29

Application Number : 21265

RX/OTC/DISCN : RX

RLD : Yes

TE Code :

Product Web Link

Digital Content

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