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Looking for 69-53-4 / Ampicillin API manufacturers, exporters & distributors?

Ampicillin manufacturers, exporters & distributors 1

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

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

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

API | Excipient name

Ampicillin

Synonyms

69-53-4, Aminobenzylpenicillin, Ampicillin acid, Amcill, Polycillin, Principen

Cas Number

69-53-4

Unique Ingredient Identifier (UNII)

7C782967RD

About Ampicillin

Semi-synthetic derivative of penicillin that functions as an orally active broad-spectrum antibiotic.

AMPICILLIN/AMPICILLIN TRIHYDRATE Manufacturers

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

AMPICILLIN/AMPICILLIN TRIHYDRATE Suppliers

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

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

AMPICILLIN/AMPICILLIN TRIHYDRATE USDMF

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

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

click here to find a list of AMPICILLIN/AMPICILLIN TRIHYDRATE suppliers with USDMF on PharmaCompass.

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

AMPICILLIN/AMPICILLIN TRIHYDRATE CEP

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

A AMPICILLIN/AMPICILLIN TRIHYDRATE CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. AMPICILLIN/AMPICILLIN TRIHYDRATE 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 AMPICILLIN/AMPICILLIN TRIHYDRATE suppliers with CEP (COS) on PharmaCompass.

AMPICILLIN/AMPICILLIN TRIHYDRATE WC

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

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

AMPICILLIN/AMPICILLIN TRIHYDRATE GMP

AMPICILLIN/AMPICILLIN TRIHYDRATE 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 AMPICILLIN/AMPICILLIN TRIHYDRATE 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 AMPICILLIN/AMPICILLIN TRIHYDRATE GMP manufacturer or AMPICILLIN/AMPICILLIN TRIHYDRATE GMP API supplier for your needs.

AMPICILLIN/AMPICILLIN TRIHYDRATE CoA

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

AMPICILLIN/AMPICILLIN TRIHYDRATE CoA mostly includes findings from lab analyses of a specific batch. For each AMPICILLIN/AMPICILLIN TRIHYDRATE 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.

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