Biphentin | Marketing Authorisations | MA | Europe | PharmaCompass.com

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Biphentin
Europe

Evonik

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Sharp is a global leader in pharmaceutical packaging and clinical trial supply services.

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xyz-pharma-m-2025-04-21

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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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USP reference standards; highly characterized specimens of drug substances, impurities, excipients, degradation products & more.

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xyz-pharma-m-2025-04-14

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Biphentin

ACCESS ALL DATA, CHEMISTRY

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CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

16 API Suppliers, 8 USDMF, 8 NDC API, 8 Listed Suppliers, $ API Reference Price

16 API Suppliers
8 USDMF
8 NDC API
8 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

51 Drugs in Development

51 Drugs in Development

INTERMEDIATES

2 Intermediate Suppliers

2 Intermediate Suppliers

FINISHED DOSAGE FORMULATIONS

120 FDF Dossiers, 112 FDA Orange Book, 8 Europe

120 FDF Dossiers
112 FDA Orange Book
8 Europe

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 10MG, TABLET;ORAL - 2.5MG, TABLET;ORAL - 5MG, CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 15MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 25MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 35MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 5MG

TABLET;ORAL - 10MG
TABLET;ORAL - 2.5MG
TABLET;ORAL - 5MG
CAPSULE, EXTENDED RELEASE;ORAL - 10MG
CAPSULE, EXTENDED RELEASE;ORAL - 15MG
CAPSULE, EXTENDED RELEASE;ORAL - 20MG
CAPSULE, EXTENDED RELEASE;ORAL - 25MG
CAPSULE, EXTENDED RELEASE;ORAL - 30MG
CAPSULE, EXTENDED RELEASE;ORAL - 35MG
CAPSULE, EXTENDED RELEASE;ORAL - 40MG
CAPSULE, EXTENDED RELEASE;ORAL - 5MG

RELATED EXCIPIENT COMPANIES

10 Evonik, 4 SPI Pharma, 10 DKSH, 4 Faran Shimi Pharmaceutical, 4 Gangwal Healthcare, 6 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 4 ACG Worldwide, 4 Actylis, 1 Aeon Procare, 1 Alcedo Pharmachem, 6 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 1 Avesta Pharma, 18 BASF, 2 Clariant, 21 Corel Pharma Chem, 6 DFE Pharma, 3 Doshion Polyscience, 2 Finar, 7 Gangwal Chemicals, 13 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 36 Kerry, 4 Kima Chemical, 6 Lonza Capsugel, 12 Microlex e.U, 2 Nomisma Healthcare, 1 Novo Excipients, 2 Pharmatrans-Sanaq, 5 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 2 Qualicaps, 18 Roquette, 8 Seppic, 4 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 11 Sigachi Industries, 3 Silverline Chemicals, 5 The Dow Chemical Company, 2 Valens Pharmachem, 3 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

71 Coating Systems & Additives, 68 Fillers, Diluents & Binders, 50 Controlled & Modified Release, 28 Thickeners and Stabilizers, 19 Film Formers & Plasticizers, 19 Granulation, 19 Taste Masking, 19 Solubilizers, 19 Direct Compression, 17 Lubricants & Glidants, 17 Disintegrants & Superdisintegrants, 15 Topical, 11 Co-Processed Excipients, 9 Empty Capsules, 7 Parenteral, 6 Chewable & Orodispersible Aids, 6 Emulsifying Agents, 5 Coloring Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 4 Surfactant & Foaming Agents, 4 API Stability Enhancers

71 Coating Systems & Additives
68 Fillers, Diluents & Binders
50 Controlled & Modified Release
28 Thickeners and Stabilizers
19 Film Formers & Plasticizers
19 Granulation
19 Taste Masking
19 Solubilizers
19 Direct Compression
17 Lubricants & Glidants
17 Disintegrants & Superdisintegrants
15 Topical
11 Co-Processed Excipients
9 Empty Capsules
7 Parenteral
6 Chewable & Orodispersible Aids
6 Emulsifying Agents
5 Coloring Agents
5 Rheology Modifiers
4 Vegetarian Capsules
4 Surfactant & Foaming Agents
4 API Stability Enhancers

DIGITAL CONTENT

1 Data Compilation #PharmaFlow, 42 News #PharmaBuzz

1 Data Compilation #PharmaFlow
42 News #PharmaBuzz

GLOBAL SALES INFORMATION

4 US Medicaid Prescriptions, 36 Regulatory FDF Prices, 6 Annual Reports

4 US Medicaid Prescriptions
36 Regulatory FDF Prices
6 Annual Reports

MARKET PLACE

2 APIs

2 APIs

PATENTS & EXCLUSIVITIES

18 US Patents, 3 US Exclusivities, 6 Health Canada Patents

18 US Patents
3 US Exclusivities
6 Health Canada Patents

$ API Ref.Price (USD/KG) : 6,715 Xls

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Sandoz Pharmaceuticals AG

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Sandoz Pharmaceuticals AG

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Regulatory Info :

Registration Country : Switzerland

Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

Dosage Form : Ret Kaps

Dosage Strength : 10mg

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Registration Country : Switzerland

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Sandoz Pharmaceuticals AG

AACR Annual meeting

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Sandoz Pharmaceuticals AG

AACR Annual meeting

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Regulatory Info :

Registration Country : Switzerland

Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

Dosage Form : Ret Kaps

Dosage Strength : 10mg

Packaging :

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Registration Country : Switzerland

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Sandoz Pharmaceuticals AG

AACR Annual meeting

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Sandoz Pharmaceuticals AG

AACR Annual meeting

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Regulatory Info :

Registration Country : Switzerland

Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

Dosage Form : Ret Kaps

Dosage Strength : 15mg

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Registration Country : Switzerland

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04

Sandoz Pharmaceuticals AG

AACR Annual meeting

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Sandoz Pharmaceuticals AG

AACR Annual meeting

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Regulatory Info :

Registration Country : Switzerland

Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

Dosage Form : Ret Kaps

Dosage Strength : 15mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Digital Content

05

Sandoz Pharmaceuticals AG

AACR Annual meeting

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Sandoz Pharmaceuticals AG

AACR Annual meeting

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Regulatory Info :

Registration Country : Switzerland

Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

Dosage Form : Ret Caps

Dosage Strength : 20mg

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Registration Country : Switzerland

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06

Sandoz Pharmaceuticals AG

AACR Annual meeting

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Sandoz Pharmaceuticals AG

AACR Annual meeting

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Regulatory Info :

Registration Country : Switzerland

Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

Dosage Form : Ret Caps

Dosage Strength : 20mg

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Registration Country : Switzerland

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Sandoz Pharmaceuticals AG

AACR Annual meeting

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Sandoz Pharmaceuticals AG

AACR Annual meeting

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Registration Country : Switzerland

Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

Dosage Form : Ret Kaps

Dosage Strength : 5mg

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Registration Country : Switzerland

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08

Sandoz Pharmaceuticals AG

AACR Annual meeting

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Sandoz Pharmaceuticals AG

AACR Annual meeting

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Regulatory Info :

Registration Country : Switzerland

Dexmethylphenidati hydrochloridum

Brand Name : Focalin XR

Dosage Form : Ret Kaps

Dosage Strength : 5mg

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Registration Country : Switzerland

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