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List of Korea Drug Master Files (KDMF) for Bupropion Active Pharmaceutical Ingredient submitted to the Review Authority in Korea and listed on PharmaCompass.com

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Flag India
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Leesung International Co., Ltd.
2020-04-02
20200402-209-J-326
Alembic Pharmaceuticals L...
India
Survey No. 144P1, 144P2, ...
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Hwail Pharmaceutical Co., Ltd.
2020-05-19
20200402-209-J-326(1)
Alembic Pharmaceuticals L...
India
Survey No. 144P1, 144P2, ...
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Samo Pharmaceutical Co., Ltd.
2021-02-05
20210205-209-J-800
Dipharma Francis Srl
Italy
Via Bissone, 5, 20021, Ba...
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Pharmaline Co., Ltd.
2022-11-10
20221110-209-J-1401
Divi's Laboratories Ltd.
India
Unit-2, 531162, Chippada ...
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Farmirae Co., Ltd.
2021-03-23
20210323-209-J-712
Erregierre SpA
Italy
Via F. Baracca, 19-24060 ...
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Seongui Bio Co., Ltd.
2020-11-04
20201104-209-J-657
Hikal Limited
India
72 & 82/A, KIADB Industri...
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FarmChem Service Co., Ltd.
2023-09-20
20201104-209-J-657(1)
Hikal Limited
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72 & 82/A, KIADB Industri...
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Hiple Co., Ltd.
2020-05-11
20200511-209-J-394
Dijia Pharmaceutical Grou...
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No.268 Tianrun Road, Wend...
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  • TABLET;ORAL - 100MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 50MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 75MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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  • TABLET, EXTENDED RELEASE;ORAL - 150MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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

Looking for 31677-93-7 / Bupropion Hydrochloride API manufacturers, exporters & distributors?

Bupropion Hydrochloride manufacturers, exporters & distributors 1

22

PharmaCompass offers a list of Bupropion Hydrochloride API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Bupropion Hydrochloride manufacturer or Bupropion Hydrochloride supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Bupropion Hydrochloride manufacturer or Bupropion Hydrochloride supplier.

PharmaCompass also assists you with knowing the Bupropion Hydrochloride API Price utilized in the formulation of products. Bupropion Hydrochloride API Price is not always fixed or binding as the Bupropion Hydrochloride Price is obtained through a variety of data sources. The Bupropion Hydrochloride Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Bupropion Hydrochloride

Synonyms

31677-93-7, Bupropion hcl, 2-(tert-butylamino)-1-(3-chlorophenyl)propan-1-one hydrochloride, Wellbutrin, Amfebutamone hydrochloride, Zyban

Cas Number

31677-93-7

Unique Ingredient Identifier (UNII)

ZG7E5POY8O

About Bupropion Hydrochloride

A propiophenone-derived antidepressant and antismoking agent that inhibits the uptake of DOPAMINE.

Bupropion Manufacturers

A Bupropion manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Bupropion, including repackagers and relabelers. The FDA regulates Bupropion manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Bupropion API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Bupropion manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Bupropion Suppliers

A Bupropion supplier is an individual or a company that provides Bupropion active pharmaceutical ingredient (API) or Bupropion finished formulations upon request. The Bupropion suppliers may include Bupropion API manufacturers, exporters, distributors and traders.

click here to find a list of Bupropion suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Bupropion KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Bupropion Drug Master File in Korea (Bupropion KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Bupropion. The MFDS reviews the Bupropion KDMF as part of the drug registration process and uses the information provided in the Bupropion KDMF to evaluate the safety and efficacy of the drug.

After submitting a Bupropion KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Bupropion API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Bupropion suppliers with KDMF on PharmaCompass.

Bupropion Manufacturers | Traders | Suppliers

Bupropion Manufacturers, Traders, Suppliers 1
80

We have 6 companies offering Bupropion

Get in contact with the supplier of your choice:

  1. Alembic Pharmaceuticals Limited
  2. Dipharma
  3. Divis Laboratories
  4. Erregierre SpA
  5. Hikal
  6. Weihai Disu Pharmacuetical Co., Ltd.
Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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