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  • TABLET;ORAL - 250MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 500MG;EQ 125MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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  • TABLET;ORAL - 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • TABLET;ORAL - 875MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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DELAYED REL PELLETS;ORAL - 500MG;500MG;30MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 200MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
  • FOR SUSPENSION;ORAL - 400MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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- 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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 USDMF

A Amoxicillin DMF (Drug Master File) is a document detailing the whole manufacturing process of Amoxicillin active pharmaceutical ingredient (API) in detail. Different forms of Amoxicillin DMFs exist exist since differing nations have different regulations, such as Amoxicillin USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Amoxicillin DMF submitted to regulatory agencies in the US is known as a USDMF. Amoxicillin USDMF includes data on Amoxicillin's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Amoxicillin USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Amoxicillin suppliers with USDMF 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 KDMF

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

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

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

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

Amoxicillin CEP

A Amoxicillin CEP of the European Pharmacopoeia monograph is often referred to as a Amoxicillin Certificate of Suitability (COS). The purpose of a Amoxicillin CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Amoxicillin EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Amoxicillin to their clients by showing that a Amoxicillin CEP has been issued for it. The manufacturer submits a Amoxicillin CEP (COS) as part of the market authorization procedure, and it takes on the role of a Amoxicillin CEP holder for the record. Additionally, the data presented in the Amoxicillin CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Amoxicillin DMF.

A Amoxicillin CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Amoxicillin CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Amoxicillin suppliers with CEP (COS) on PharmaCompass.

Amoxicillin WC

A Amoxicillin written confirmation (Amoxicillin WC) is an official document issued by a regulatory agency to a Amoxicillin manufacturer, verifying that the manufacturing facility of a Amoxicillin active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Amoxicillin APIs or Amoxicillin finished pharmaceutical products to another nation, regulatory agencies frequently require a Amoxicillin WC (written confirmation) as part of the regulatory process.

click here to find a list of Amoxicillin suppliers with Written Confirmation (WC) on PharmaCompass.

Amoxicillin NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Amoxicillin as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Amoxicillin API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Amoxicillin as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Amoxicillin and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Amoxicillin NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Amoxicillin suppliers with NDC on PharmaCompass.

Amoxicillin GMP

Amoxicillin Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

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

Amoxicillin CoA

A Amoxicillin CoA (Certificate of Analysis) is a formal document that attests to Amoxicillin's compliance with Amoxicillin specifications and serves as a tool for batch-level quality control.

Amoxicillin CoA mostly includes findings from lab analyses of a specific batch. For each Amoxicillin CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Amoxicillin may be tested according to a variety of international standards, such as European Pharmacopoeia (Amoxicillin EP), Amoxicillin JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Amoxicillin USP).

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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