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

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01 LABORATORIOS ESPINOS Y BOFILL SA (LEBSA) (1)

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01 GMAX Pharmachem Co., Ltd. (1)

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01 Betahistine dihydrochloride (1)

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01 Spain (1)

GMAX Pharmachem Co., Ltd.
2022-09-16
20220916-211-J-1364
LABORATORIOS ESPINOS Y BO...
Spain
Ctra. De L'Hospitalet, 34...

Looking for 5579-84-0 / Betahistine Dihydrochloride API manufacturers, exporters & distributors?

Betahistine Dihydrochloride manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Betahistine Dihydrochloride

Synonyms

5579-84-0, Betahistine hydrochloride, Betahistine 2hcl, Betahistine hcl, Serc, Betaserc

Cas Number

5579-84-0

Unique Ingredient Identifier (UNII)

49K58SMZ7U

About Betahistine Dihydrochloride

A histamine analog and H1 receptor agonist that serves as a vasodilator. It is used in MENIERE DISEASE and in vascular headaches but may exacerbate bronchial asthma and peptic ulcers.

Betahistine Hydrochloride Manufacturers

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

Betahistine Hydrochloride Suppliers

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

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

Betahistine Hydrochloride KDMF

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

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

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

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

Betahistine Hydrochloride Manufacturers | Traders | Suppliers

Betahistine Hydrochloride Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Betahistine Hydrochloride

Get in contact with the supplier of your choice:

  1. LEBSA
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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