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

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01 Pharmaceutical Works Polpharma S.A. (6)

02 Cohance Lifesciences Limited (1)

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01 Aging Life Science Co., Ltd. (1)

02 Hwail Pharmaceutical Co., Ltd. (1)

03 IMCD Korea Co., Ltd. (1)

04 Kookjeon Pharmaceutical Co., Ltd. (1)

05 Korea United Pharmaceutical Co., Ltd. (1)

06 Taejun Pharmaceutical Co., Ltd. (1)

07 Wooshin Rabotachi Co., Ltd. (1)

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01 Baclofen (7)

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01 India (1)

02 Poland (6)

Wooshin Rabotachi Co., Ltd.
2019-08-02
20181018-209-J-161(5)
Pharmaceutical Works Polp...
Poland
19, Pelplinska Street. 83...
Hwail Pharmaceutical Co., Ltd.
2018-12-03
20181018-209-J-161(1)
Pharmaceutical Works Polp...
Poland
19, Pelplinska Street. 83...
IMCD Korea Co., Ltd.
2018-10-18
20181018-209-J-161
Pharmaceutical Works Polp...
Poland
19, Pelplinska Street. 83...
Korea United Pharmaceutical Co., Ltd.
2019-01-24
20181018-209-J-161(3)
Pharmaceutical Works Polp...
Poland
19, Pelplinska Str.83-200...
Taejun Pharmaceutical Co., Ltd.
2019-06-14
20181018-209-J-161(4)
Pharmaceutical Works Polp...
Poland
19, Pelplinska Street. 83...
Kookjeon Pharmaceutical Co., Ltd.
2019-01-11
20181018-209-J-161(2)
Pharmaceutical Works Polp...
Poland
19, Pelplinska Street. 83...
URL Supplier Web Content
Aging Life Science Co., Ltd.
2021-06-29
20210629-209-J-1043
Cohance Lifesciences Limi...
India
RS 50/1, Mukteswarapuram ...
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Looking for 1134-47-0 / Baclofen API manufacturers, exporters & distributors?

Baclofen manufacturers, exporters & distributors 1

39

PharmaCompass offers a list of Baclofen 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 Baclofen manufacturer or Baclofen supplier for your needs.

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

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

API | Excipient name

Baclofen

Synonyms

1134-47-0, Lioresal, 4-amino-3-(4-chlorophenyl)butanoic acid, Kemstro, Baclon, Dl-baclofen

Cas Number

1134-47-0

Unique Ingredient Identifier (UNII)

H789N3FKE8

About Baclofen

A GAMMA-AMINOBUTYRIC ACID derivative that is a specific agonist of GABA-B RECEPTORS. It is used in the treatment of MUSCLE SPASTICITY, especially that due to SPINAL CORD INJURIES. Its therapeutic effects result from actions at spinal and supraspinal sites, generally the reduction of excitatory transmission.

Baclofen Manufacturers

A Baclofen manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Baclofen, including repackagers and relabelers. The FDA regulates Baclofen manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Baclofen 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 Baclofen manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Baclofen Suppliers

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

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

Baclofen KDMF

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

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

After submitting a Baclofen 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 Baclofen API can apply through the Korea Drug Master File (KDMF).

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

Baclofen Manufacturers | Traders | Suppliers

Baclofen Manufacturers, Traders, Suppliers 1
39

We have 2 companies offering Baclofen

Get in contact with the supplier of your choice:

  1. Polpharma
  2. RA CHEM PHARMA LIMITED
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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