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List of Drug Master Files (KDMF) for Bupropion Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Korea.

Client Email

Product

Bupropion
Bupropion Hydrobromide
CAS 34911-51-8
KDMF

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Bora Pharmaceuticals- Making success more certain.

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

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Axplora- The partner of choice for complex APIs.

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Fareva is a one-stop-shop for API/HPAPI, OSD & Sterile products, is USFDA, EMA and PMDA-inspected and has multiple NDA & ANDA filings.

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Bupropion

ACCESS ALL DATA, CHEMISTRY

ACCESS ALL DATA
Browse all information
CHEMISTRY
Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

58 API Suppliers, 37 USDMF, 10 EU WC, 8 KDMF, 33 NDC API, 34 Listed Suppliers, $ API Reference Price

58 API Suppliers
37 USDMF
10 EU WC
8 KDMF
33 NDC API
34 Listed Suppliers
$ API Reference Price

DEVELOPMENTS

29 Drugs in Development

29 Drugs in Development

PRICE INFORMATION

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

API Reference Price
API Exports
API Imports
FDF Imports

INTERMEDIATES

5 API Suppliers

5 API Suppliers

FINISHED DOSAGE FORMULATIONS

264 FDF Dossiers, 130 FDA Orange Book, 85 Europe, 12 Canada, 2 Australia, 17 South Africa, 18 Listed Dossiers

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TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 90MG;8MG, TABLET, EXTENDED RELEASE;ORAL - 100MG, TABLET, EXTENDED RELEASE;ORAL - 150MG,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- 200MG, TABLET, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET, EXTENDED RELEASE;ORAL - 150MG, TABLET, EXTENDED RELEASE;ORAL - 300MG, TABLET, EXTENDED RELEASE;ORAL - 450MG

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, 3 Boai NKY Pharmaceuticals Ltd, 1 Chynops Pharma, 12 Gangwal Healthcare, 10 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

105 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, 23 Parenteral, 21 Topical, 19 Co-Processed Excipients, 18 Disintegrants & Superdisintegrants, 17 Chewable & Orodispersible Aids, 11 Emulsifying Agents, 8 API Stability Enhancers, 7 Rheology Modifiers, 5 Coloring Agents, 5 Empty Capsules, 5 Surfactant & Foaming Agents, 4 Vegetarian Capsules

105 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
23 Parenteral
21 Topical
19 Co-Processed Excipients
18 Disintegrants & Superdisintegrants
17 Chewable & Orodispersible Aids
11 Emulsifying Agents
8 API Stability Enhancers
7 Rheology Modifiers
5 Coloring Agents
5 Empty Capsules
5 Surfactant & Foaming Agents
4 Vegetarian Capsules

DIGITAL CONTENT

4 DATA COMPILATION #PharmaFlow, 90 NEWS #PharmaBuzz

4 DATA COMPILATION #PharmaFlow
90 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

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

6 US Medicaid Prescriptions
62 Finished Drug Prices
10 Annual Reports

MARKET PLACE

10 APIs, 2 FDF Dossiers

10 APIs
2 FDF Dossiers

PATENTS & EXCLUSIVITIES

23 US Patents, 30 Health Canada Patents

23 US Patents
30 Health Canada Patents

REF. STANDARDS & IMPURITIES

5 USP, 8 Others

5 USP
8 Others

ANALYTICAL

2 BioAnalytical Methods

2 BioAnalytical Methods

$ API Ref.Price (USD/KG) : 63 Xls

Filters

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Filters

FILTER :

filter Manufacturer Reset all filters

8 All

01 2Alembic Pharmaceuticals Limited (API Division-II)

02 1Dijia Pharmaceutical Group Co., Ltd

03 1Dipharma Francis Srl

04 1Divi's Laboratories Ltd.

05 1Erregierre SpA

06 2Hikal Limited

filter Registrant Name Reset all filters

8 All

01 1Hiple Co., Ltd.

02 1Hwail Pharmaceutical Co., Ltd.

03 1Lee Sung International Co., Ltd.

04 1Pami Future Co., Ltd.

05 1Parmarine Co., Ltd.

06 1Phamchem Service Co., Ltd.

07 1Samoh Pharmaceutical Co., Ltd.

08 1Seongi Bio Co., Ltd.

filter Product Name Reset all filters

8 All

01 8Bupropion hydrochloride

filter Country Reset all filters

8 All

01 1China

02 5India

03 2Italy

API Suppliers
USDMF
EU WC
KDMF
NDC API
Listed Suppliers

List of Suppliers

Product Main Page

01

Alembic Pharmaceuticals Limited

FNCE 2024

Not Confirmed

Alembic Pharmaceuticals Limited

FNCE 2024

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.

Post an Enquiry

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Digital Content

Bupropion hydrochloride

Registrant Name : Lee Sung International Co., Ltd.

Registration Date : 2020-04-02

Registration Number : 20200402-209-J-326

Manufacturer Name : Alembic Pharmaceuticals Limi...

Manufacturer Address : Survey No. 144P1, 144P2, 144P3, 145P, 137, 138, 139, 140, Panelav, Tal-Halol, Dist.-P...

Product Web Link

Digital Content

02

Alembic Pharmaceuticals Limited

FNCE 2024

Not Confirmed

Alembic Pharmaceuticals Limited

FNCE 2024

Not Confirmed

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Digital Content

Bupropion hydrochloride

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2020-05-19

Registration Number : 20200402-209-J-326(1)

Manufacturer Name : Alembic Pharmaceuticals Limi...

Manufacturer Address : Survey No. 144P1, 144P2, 144P3, 145P, 137, 138, 139, 140, Panelav, Tal-Halol, Dist.-P...

Product Web Link

Digital Content

03

Dipharma

FNCE 2024

Not Confirmed

Dipharma

FNCE 2024

Not Confirmed

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Digital Content

Bupropion hydrochloride

Registrant Name : Samoh Pharmaceutical Co., Ltd.

Registration Date : 2021-02-05

Registration Number : 20210205-209-J-800

Manufacturer Name : Dipharma Francis Srl

Manufacturer Address : Via Bissone, 5, 20021, Baranzate (MI), Italy

Product Web Link

Digital Content

04

Divis Laboratories

FNCE 2024

Not Confirmed

Divis Laboratories

FNCE 2024

Not Confirmed

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Digital Content

Bupropion hydrochloride

Registrant Name : Parmarine Co., Ltd.

Registration Date : 2022-11-10

Registration Number : 20221110-209-J-1401

Manufacturer Name : Divi's Laboratories Ltd.

Manufacturer Address : Unit-2, 531162, Chippada Village, Annavaram, Bheemunipatnam Mandal, Visakhapatnam Dis...

Product Web Link

Digital Content

Corporate PDF

05

Erregierre SpA

FNCE 2024

Not Confirmed

Erregierre SpA

FNCE 2024

Not Confirmed

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Digital Content

Bupropion hydrochloride

Registrant Name : Pami Future Co., Ltd.

Registration Date : 2021-03-23

Registration Number : 20210323-209-J-712

Manufacturer Name : Erregierre SpA

Manufacturer Address : Via F. Baracca, 19-24060 SAN PAOLO D'ARGON (BG), Italy

Product Web Link

Digital Content

Corporate PDF

06

Hikal

FNCE 2024

Not Confirmed

Hikal

FNCE 2024

Not Confirmed

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Digital Content

Bupropion hydrochloride

Registrant Name : Phamchem Service Co., Ltd.

Registration Date : 2023-09-20

Registration Number : 20201104-209-J-657(1)

Manufacturer Name : Hikal Limited

Manufacturer Address : 72 & 82/A, KIADB Industrial Area, Jigani, Anekal Taluk, Bangalore, 560105, India

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

07

Hikal

FNCE 2024

Not Confirmed

Hikal

FNCE 2024

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.

Post an Enquiry

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Digital Content

Bupropion hydrochloride

Registrant Name : Seongi Bio Co., Ltd.

Registration Date : 2020-11-04

Registration Number : 20201104-209-J-657

Manufacturer Name : Hikal Limited

Manufacturer Address : 72 & 82/A, KIADB Industrial Area, Jigani, Anekal Taluk, Bangalore, 560105, India

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

08

Weihai Disu Pharmacuetical Co., Ltd...

FNCE 2024

Not Confirmed

Weihai Disu Pharmacuetical Co., Ltd...

FNCE 2024

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.

Post an Enquiry

Post an Enquiry

Digital Content

Bupropion hydrochloride

Registrant Name : Hiple Co., Ltd.

Registration Date : 2020-05-11

Registration Number : 20200511-209-J-394

Manufacturer Name : Dijia Pharmaceutical Group C...

Manufacturer Address : No.268 Tianrun Road, Wendeng Economic Development Zone, Weihai China

Portfolio PDF

Product Web Link

Digital Content

Corporate PDF

Bupropion Manufacturers | Traders | Suppliers

Bupropion Manufacturers, Traders, Suppliers 1

59

We have 6 companies offering Bupropion

Get in contact with the supplier of your choice:

Alembic Pharmaceuticals Limited
Dipharma
Divis Laboratories
Erregierre SpA
Hikal
Weihai Disu Pharmacuetical Co., Ltd.

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