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List of Drug Master Files (JDMF) for Betaine Hydrate Active Pharmaceutical Ingredient (API) submitted to the Review Authority in Japan (PMDA). Original Data : PMDA Database

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01 AMINO GmbH (1)

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01 Betaine anhydrous (1)

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01 Germany (1)

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225MF10183
An der Zucker-Raffinerie 9, 38373 F...
2023-09-13
2013-09-25
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Looking for 107-43-7 / Betaine API manufacturers, exporters & distributors?

Betaine manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Betaine

Synonyms

107-43-7, Glycine betaine, Oxyneurine, Trimethylglycine, Lycine, Abromine

Cas Number

107-43-7

Unique Ingredient Identifier (UNII)

3SCV180C9W

About Betaine

A naturally occurring compound that has been of interest for its role in osmoregulation. As a drug, betaine hydrochloride has been used as a source of hydrochloric acid in the treatment of hypochlorhydria. Betaine has also been used in the treatment of liver disorders, for hyperkalemia, for homocystinuria, and for gastrointestinal disturbances. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1341)

Betaine Hydrate Manufacturers

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

Betaine Hydrate Suppliers

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

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

Betaine Hydrate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Betaine Hydrate Drug Master File in Japan (Betaine Hydrate JDMF) empowers Betaine Hydrate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Betaine Hydrate JDMF during the approval evaluation for pharmaceutical products. At the time of Betaine Hydrate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Betaine Hydrate suppliers with JDMF on PharmaCompass.

Betaine Hydrate Manufacturers | Traders | Suppliers

Betaine Hydrate Manufacturers, Traders, Suppliers 1
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We have 1 companies offering Betaine Hydrate

Get in contact with the supplier of your choice:

  1. AMINO GmbH
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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