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Bupropion

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ACTIVE PHARMA INGREDIENTS

60 API Suppliers, 38 USDMF, 10 EU WC, 8 KDMF, 33 NDC API, 35 Listed Suppliers, $ API Reference Price

DEVELOPMENTS

29 Drugs in Development

29 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

267 FDF Dossiers, 133 FDA Orange Book, 85 Europe, 12 Canada, 2 Australia, 17 South Africa, 18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG, TABLET, EXTENDED RELEASE;ORAL - 100MG, TABLET, EXTENDED RELEASE;ORAL - 150MG, TABLET, EXTENDED RELEASE;ORAL - 200MG, TABLET, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG, TABLET, EXTENDED RELEASE;ORAL - 300MG, TABLET, EXTENDED RELEASE;ORAL - 450MG

RELATED EXCIPIENT COMPANIES

1 Minakem, 2 Evonik, 2 Rochem International Inc, 19 SPI Pharma, 2 Seqens, 14 DKSH, 2 Jai Radhe Sales, 7 Faran Shimi Pharmaceutical, 3 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 9 Nanjing Well Pharmaceutical, 1 Pfanstiehl, 1 ACG Worldwide, 6 Actylis, 1 Aeon Procare, 4 Alcedo Pharmachem, 8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 35 BASF, 2 Clariant, 16 Corel Pharma Chem, 5 DFE Pharma, 3 Doshion Polyscience, 3 Finar, 12 Gangwal Chemicals, 1 Huzhou Sunflower Pharmaceutical, 15 Ideal Cures Pvt Ltd, 3 Ingredion Pharma Solutions, 39 Kerry, 5 Kima Chemical, 6 Lonza Capsugel, 21 Microlex e.U, 1 Nanjing Bold Chemical, 1 NEWEDGE Overseas, 2 Nomisma Healthcare, 4 Novo Excipients, 3 Pharmatrans-Sanaq, 7 Pluviaendo, 3 Prachin Chemical, 1 Qianhao Chemical (Hebei) Co., Ltd, 1 Qualicaps, 19 Roquette, 14 Seppic, 5 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 1 Shijiazhuang Huaxu Pharmaceutical, 10 Sigachi Industries, 4 The Dow Chemical Company, 1 Ulanqab Kema New Material, 2 Valens Pharmachem, 2 Vasa Pharmachem, 2 Vertellus

EXCIPIENTS BY APPLICATIONS

106 Fillers, Diluents & Binders, 80 Coating Systems & Additives, 51 Controlled & Modified Release, 48 Direct Compression, 36 Solubilizers, 31 Lubricants & Glidants, 30 Granulation, 30 Thickeners and Stabilizers, 29 Film Formers & Plasticizers, 27 Taste Masking, 22 Parenteral, 21 Topical, 20 Co-Processed Excipients, 18 Disintegrants & Superdisintegrants, 17 Chewable & Orodispersible Aids, 11 Emulsifying Agents, 8 API Stability Enhancers, 7 Rheology Modifiers, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 5 Coloring Agents, 4 Vegetarian Capsules

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 90 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

6 US Medicaid Prescriptions, 62 Finished Drug Prices, 10 Annual Reports

MARKET PLACE

10 APIs, 2 FDF Dossiers

PATENTS & EXCLUSIVITIES

23 US Patents, 30 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 USP, 8 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

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Last Updated on PharmaCompass	Virtual Booth	Country	Holder	DMF No.	Subject	Submission Date	Status	Type	GDUFA DMF Review	GDUFA Review Date	GDUFA Payment Date
28/10/2024	Granules India Limited	India	GRANULES INDIA LTD	35694	BUPROPION HYDROCHLORIDE USP	2021-03-29	Active	II	Complete	2021-05-27	2021-04-15
28/10/2024	Aarti Pharmalabs	India	AARTI PHARMALABS LTD	27204	BUPROPION HYDROCHLORIDE	2013-06-17	Active	II	Complete	2013-10-19	2013-06-25

Bupropion

Bupropion

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

60 API Suppliers

38 USDMF

10 EU WC

8 KDMF

33 NDC API

35 Listed Suppliers

$ API Reference Price

DEVELOPMENTS

29 Drugs in Development

INTERMEDIATES

5 Intermediates Suppliers

FINISHED DOSAGE FORMULATIONS

267 FDF Dossiers

133 FDA Orange Book

85 Europe

12 Canada

2 Australia

17 South Africa

18 Listed Dossiers

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG

TABLET, EXTENDED RELEASE;ORAL - 100MG

TABLET, EXTENDED RELEASE;ORAL - 150MG

TABLET, EXTENDED RELEASE;ORAL - 200MG

TABLET, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

TABLET, EXTENDED RELEASE;ORAL - 150MG

TABLET, EXTENDED RELEASE;ORAL - 300MG

TABLET, EXTENDED RELEASE;ORAL - 450MG

RELATED EXCIPIENT COMPANIES

1 Minakem

2 Evonik

2 Rochem International Inc

19 SPI Pharma

2 Seqens

14 DKSH

2 Jai Radhe Sales

7 Faran Shimi Pharmaceutical

3 Boai NKY Pharmaceuticals Ltd

1 Chynops Pharma

12 Gangwal Healthcare

9 Nanjing Well Pharmaceutical

1 Pfanstiehl

1 ACG Worldwide

6 Actylis

1 Aeon Procare

4 Alcedo Pharmachem

8 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

35 BASF

2 Clariant

16 Corel Pharma Chem

5 DFE Pharma

3 Doshion Polyscience

3 Finar

12 Gangwal Chemicals

1 Huzhou Sunflower Pharmaceutical

15 Ideal Cures Pvt Ltd

3 Ingredion Pharma Solutions

39 Kerry

5 Kima Chemical

6 Lonza Capsugel

21 Microlex e.U

1 Nanjing Bold Chemical

1 NEWEDGE Overseas

2 Nomisma Healthcare

4 Novo Excipients

3 Pharmatrans-Sanaq

7 Pluviaendo

3 Prachin Chemical

1 Qianhao Chemical (Hebei) Co., Ltd

1 Qualicaps

TABLET;ORAL - 100MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 50MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET;ORAL - 75MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons

TABLET, EXTENDED RELEASE;ORAL - 150MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons