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List of Japan Drug Master File (JDMF) for Amoxicillin Active Pharmaceutical Ingredient submitted to the Review Authority in Japan (PMDA) and listed on PharmaCompass.com

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Centrient Pharmaceuticals

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  • TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 125MG/5ML;EQ 31.25MG BASE/5ML
  • FOR SUSPENSION;ORAL - 250MG/5ML;EQ 62.5MG BASE/5ML
  • TABLET;ORAL - 875MG;EQ 125MG BASE
  • FOR SUSPENSION;ORAL - 200MG/5ML;EQ 28.5MG BASE/5ML
  • FOR SUSPENSION;ORAL - 400MG/5ML;EQ 57MG BASE/5ML
  • TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 600MG/5ML;EQ 42.9MG BASE/5ML
  • CAPSULE, TABLET, CAPSULE, DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET, EXTENDED RELEASE;ORAL - 1GM;EQ 62.5MG BASE
  • TABLET, EXTENDED RELEASE;ORAL - 775MG
  • CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL - 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Looking for 61336-70-7 / Amoxicillin Trihydrate API manufacturers, exporters & distributors?

Amoxicillin Trihydrate manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Amoxicillin Trihydrate

Synonyms

61336-70-7, Larotid, Polymox, Trimox, Utimox, Wymox

Cas Number

61336-70-7

Unique Ingredient Identifier (UNII)

804826J2HU

About Amoxicillin Trihydrate

A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.

Amoxicillin Manufacturers

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

Amoxicillin Suppliers

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

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

Amoxicillin 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 Amoxicillin Drug Master File in Japan (Amoxicillin JDMF) empowers Amoxicillin 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 Amoxicillin JDMF during the approval evaluation for pharmaceutical products. At the time of Amoxicillin 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 Amoxicillin suppliers with JDMF on PharmaCompass.

Amoxicillin Manufacturers | Traders | Suppliers

Amoxicillin Manufacturers, Traders, Suppliers 1
46

We have 5 companies offering Amoxicillin

Get in contact with the supplier of your choice:

  1. Centrient Pharmaceuticals
  2. ADL BioPharma
  3. Daewoong Pharmaceutical
  4. Sandoz B2B
  5. Zhuhai United Laboratories 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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