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Manufacturers & Suppliers of Prestwick3_000161 Licensing, EU CTD Dossiers, Marketing Authorizations, Finished Dosage Formulations listed on PharmaCompass.com

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Prestwick3_000161
Listed Dossiers

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_000161

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

13 API Suppliers, 7 USDMF, 5 CEP/COS, 1 JDMF, 2 EU WC, 5 NDC API, 5 Listed Suppliers, $ API Reference Price

13 API Suppliers
7 USDMF
5 CEP/COS
1 JDMF
2 EU WC
5 NDC API
5 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

1 Drugs in Development

1 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

154 FDF Dossiers, 61 FDA Orange Book, 19 Europe, 3 Canada, 1 Australia, 56 South Africa, 14 Listed Dossiers

154 FDF Dossiers
61 FDA Orange Book
19 Europe
3 Canada
1 Australia
56 South Africa
14 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 50MG;300MG;120MG, TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SYRUP;ORAL - 50MG/5ML

TABLET;ORAL - 50MG;300MG;120MG
TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 300MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SYRUP;ORAL - 50MG/5ML

RELATED EXCIPIENT COMPANIES

3 Rochem International Inc, 12 SPI Pharma, 10 DKSH, 1 Jai Radhe Sales, 4 Boai NKY Pharmaceuticals Ltd, 14 Gangwal Healthcare, 4 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 4 Actylis, 2 Aeon Procare, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 17 BASF, 7 DFE Pharma, 1 Finar, 7 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 4 Ingredion Pharma Solutions, 26 Kerry, 1 Kima Chemical, 3 Lonza Capsugel, 18 Microlex e.U, 1 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 4 Prachin Chemical, 1 Qualicaps, 27 Roquette, 2 Seppic, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 12 Sigachi Industries, 1 The Dow Chemical Company, 2 Ulanqab Kema New Material, 1 Valens Pharmachem, 6 Vasa Pharmachem, 1 Zhejiang Huakang Pharmaceutical

EXCIPIENTS BY APPLICATIONS

82 Fillers, Diluents & Binders, 37 Direct Compression, 30 Disintegrants & Superdisintegrants, 28 Thickeners and Stabilizers, 24 Lubricants & Glidants, 23 Granulation, 20 Coating Systems & Additives, 20 Co-Processed Excipients, 16 Film Formers & Plasticizers, 14 Solubilizers, 13 Taste Masking, 13 Controlled & Modified Release, 12 Parenteral, 8 Chewable & Orodispersible Aids, 8 Empty Capsules, 7 Topical, 6 Emulsifying Agents, 5 Rheology Modifiers, 3 Coloring Agents, 3 API Stability Enhancers, 1 Surfactant & Foaming Agents, 1 Soft Gelatin

82 Fillers, Diluents & Binders
37 Direct Compression
30 Disintegrants & Superdisintegrants
28 Thickeners and Stabilizers
24 Lubricants & Glidants
23 Granulation
20 Coating Systems & Additives
20 Co-Processed Excipients
16 Film Formers & Plasticizers
14 Solubilizers
13 Taste Masking
13 Controlled & Modified Release
12 Parenteral
8 Chewable & Orodispersible Aids
8 Empty Capsules
7 Topical
6 Emulsifying Agents
5 Rheology Modifiers
3 Coloring Agents
3 API Stability Enhancers
1 Surfactant & Foaming Agents
1 Soft Gelatin

DIGITAL CONTENT

9 NEWS #PharmaBuzz

9 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions, 22 Finished Drug Prices

1 US Medicaid Prescriptions
22 Finished Drug Prices

MARKET PLACE

11 APIs, 5 FDF Dossiers

11 APIs
5 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 EDQM, 1 USP, 1 Others

1 EDQM
1 USP
1 Others

ANALYTICAL

2 Analytical Methods

2 Analytical Methods

$ API Ref.Price (USD/KG) : 18 Xls

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14 All

01 1Polfa Tarchomin

02 2Antibiotice SA

03 1Bahrain Pharma

04 1Cadila Pharmaceuticals

05 1DANHSON

06 1Grupo Chemo

07 2Holden Medical Laboratories Pvt. Ltd

08 2Pannon

09 2Umedica Laboratories Pvt Ltd

10 1Varichem Pharmaceuticals Pvt Ltd

filter Active Ingredients Reset all filters

14 All

01 12Isoniazid

02 1Rifampicin; Isoniazid

03 1Rifampin; Isoniazid

filter Dosage Reset all filters

14 All

01 1Film Coated Tablet

02 1Hard Capsule

03 1SYRUP

04 4TABLET

05 5Tablet

06 2tablets

filter Dosage Strength Reset all filters

14 All

01 6100MG

02 1150MG; 100MG

03 1300; 150MG

04 4300MG

05 1300mg

06 150MG/5ML

filter Country Reset all filters

14 All

01 1Bahrain

02 1Bulgaria

03 1Costa Rica

04 2Hungary

05 5India

06 1Poland

07 2Romania

08 1Zimbabwe

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

List of Suppliers

Product Main Page

01

Polfa Tarchomin

CPhI Worldwide, Milan

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Regulatory Info : Dossier Availability: Q4 2026

Registration Country : Poland

Rifampin; Isoniazid

Brand Name :

Dosage Form : Hard Capsule

Dosage Strength : 150MG; 100MG

Packaging :

Approval Date :

Application Number :

Regulatory Info : Dossier Availability: Q4 2026

Registration Country : Poland

Polfa Tarchomin

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01

Polfa Tarchomin

CPhI Worldwide, Milan

Polfa Tarchomin is a leading Polish pharmaceutical company with 200 year tradition in manufacture and sale of pharmaceutical products.

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Packaging :

Regulatory Info : Dossier Availability: Q4 2026

Rifampin; Isoniazid

Dosage : Hard Capsule

Dosage Strength : 150MG; 100MG

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Approval Date :

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Registration Country : Poland

Polfa Tarchomin

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02

Antibiotice SA

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Registration Country : Romania

Brand Name : ISONIAZID Atb®

Dosage Form : tablets

Dosage Strength : 100MG

Packaging : Box x 20 tablets Box x 1500 tablets

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Registration Country : Romania

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Packaging : Box x 20 tablets Box x 1500 tablets

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Dosage : tablets

Dosage Strength : 100MG

Brand Name : ISONIAZID Atb®

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Registration Country : Romania

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Registration Country : Romania

Brand Name : ISONIAZID Atb®

Dosage Form : tablets

Dosage Strength : 300MG

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Registration Country : Romania

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Packaging : Box x 30 tablets Box x 1500 tablets

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Dosage : tablets

Dosage Strength : 300MG

Brand Name : ISONIAZID Atb®

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Registration Country : Romania

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Regulatory Info : Generic

Registration Country : Bahrain

Brand Name : Isonaz

Dosage Form : SYRUP

Dosage Strength : 50MG/5ML

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Approval Date :

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Regulatory Info : Generic

Registration Country : Bahrain

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Regulatory Info : Generic

Dosage : SYRUP

Dosage Strength : 50MG/5ML

Brand Name : Isonaz

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Registration Country : Bahrain

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Cadila Pharmaceuticals

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Dosage : Tablet

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DANHSON

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Registration Country : Bulgaria

Brand Name : Isonid

Dosage Form : Tablet

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Regulatory Info : Generics

Registration Country : Costa Rica

Brand Name : isoniazid CHEMO®

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Dosage Strength : 300MG

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Registration Country : Costa Rica

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Holden Medical Laboratories Pvt. Ltd

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Holden Medical Laboratories Pvt. Ltd

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Holden Medical Laboratories Pvt. Ltd

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Pannon

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Registration Country : Hungary

Brand Name : Isonicid

Dosage Form : Tablet

Dosage Strength : 100MG

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Registration Country : Hungary

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Pannon

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Dosage : Tablet

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Pannon

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Regulatory Info :

Registration Country : Hungary

Rifampicin; Isoniazid

Brand Name : Rifazid

Dosage Form : Film Coated Tablet

Dosage Strength : 300; 150MG

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Registration Country : Hungary

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Pannon

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Regulatory Info :

Rifampicin; Isoniazid

Dosage : Film Coated Tablet

Dosage Strength : 300; 150MG

Brand Name : Rifazid

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Application Number :

Registration Country : Hungary

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12

Umedica Laboratories Pvt Ltd

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Regulatory Info : Generic

Registration Country : India

Brand Name :

Dosage Form : TABLET

Dosage Strength : 100MG

Packaging : Blister of 10s

Approval Date :

Application Number : 80936

Regulatory Info : Generic

Registration Country : India

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Packaging : Blister of 10s

Regulatory Info : Generic

Dosage : TABLET

Dosage Strength : 100MG

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Approval Date :

Application Number : 80936

Registration Country : India

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Umedica Laboratories Pvt Ltd

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Regulatory Info : Generic

Registration Country : India

Brand Name :

Dosage Form : TABLET

Dosage Strength : 300MG

Packaging : Blister of 10s

Approval Date :

Application Number : 80937

Regulatory Info : Generic

Registration Country : India

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Umedica Laboratories Pvt Ltd

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Packaging : Blister of 10s

Regulatory Info : Generic

Dosage : TABLET

Dosage Strength : 300MG

Brand Name :

Approval Date :

Application Number : 80937

Registration Country : India

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Varichem Pharmaceuticals Pvt Ltd

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Regulatory Info : Generic

Registration Country : Zimbabwe

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Dosage Form : TABLET

Dosage Strength : 100MG

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Regulatory Info : Generic

Registration Country : Zimbabwe

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Varichem Pharmaceuticals Pvt Ltd

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Registration Country : Zimbabwe

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