Looking for Dirithromycin API 62013-04-1?
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Description:
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Here you will find a list of producers, manufacturers and distributors of Dirithromycin. You can filter on certificates such as GMP, FDA, CEP, Written Confirmation and more. Send inquiries for free and get in direct contact with the supplier of your choice.
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API | Excipient name:
- Dirithromycin
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Cas Number:
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62013-04-1
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DrugBank number:
- DB00954
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Unique Ingredient Identifier:
- 1801D76STL
About Dirithromycin
So, what does it do? Dirithromycin is a macrolide glycopeptide antibiotic used to treat many different types of bacterial infections, such as bronchitis, pneumonia, tonsillitis, and even skin infections.
More information such as the structure, indication or toxicity is available on Drugbank, click the ID above.
Certificate of Analysis
A CoA is a document issued by a companies’ QA/QC-department that confirms that a product meets its product specification and is part of the quality control of a product batch. The CoA commonly contains results obtained from laboratory tests of an individual batch of a product. There are different international standards to which a product can be tested, for example: Ph. Eur. | EP – (European Pharmacopoeia) USP – (United States Pharmacopeia)
Food & Drug Administration approved
The Food and Drug Administration is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. FDA is important because it is intended to have companies produce their goods to certain standards and it presents this fact in a clear overview using FDA certificates. When a company is (US) FDA approved, it shows the American government has declared the API or medicine as safe and it can be sold, imported, or used in the United States. The USA is not the only country with a regulatory agency like FDA. Most other countries have agencies that are responsible for the national safety of pharmaceutical products. Some different kinds of organizations include:
EMA (European Medicines Agency, European Union)
MHRA (Medicines and Healthcare products Regulatory Agency, United Kingdom)
PMDA (Pharmaceuticals and Medical Devices Agency, Japan)
CDSCO (Central Drugs Standard Control Organization, India)
Good Manufacturing Practices
Active pharmaceutical ingredients are made in GMP-certified manufacturing facilities. GMP stands for Good Manufacturing Practices and is the main standard in the pharmaceutical industry. cGMP or Current GMP means that the company complies with the most recent requirements/version of GMP. The WHO has its own guideline for GMP, the World Health Organization or WHO GMP. The authority that has audited the company can also be from a country like China (Chinese GMP) or from the EU (EU GMP), every authority has different GMP requirements.
Certificate of Suitability
CEP (also known as COS) is a certificate that proves that qualifies to the relevant monograph of the European Pharmacopoeia. It links the monograph in the Ph.Eur. to the API itself. A CEP is submitted by the manufacturer as part of the market authorization process, and they will become the CEP holder of the document. Being a European certificate, the CEP is granted by the EDQM but is recognized by other countries or institutes such as the FDA in the US. Furthermore, just like the DMF, the data as submitted in the CEP is handled strictly confidential and provides a centralized system recognized by many countries.
HALAL Certificate in Pharmaceuticals: Ensuring Compliance with Islamic Standards
A HALAL certificate in the pharmaceutical industry guarantees that products are manufactured, processed, and handled according to Islamic dietary laws. This certification ensures that pharmaceutical products, including Active Pharmaceutical Ingredients (API) and finished formulations, meet stringent HALAL criteria, which prohibits the use of haram (forbidden) substances and ensures hygiene and ethical sourcing practices.
By obtaining a HALAL certificate, pharmaceutical companies can access a broader market, including consumers who require HALAL-compliant medications and health supplements. It also demonstrates a commitment to quality and safety, aligning with global standards and fostering trust among Muslim consumers worldwide.
Kosher Certificate in Pharmaceuticals
A Kosher certificate in the pharmaceutical industry ensures that products are manufactured, processed, and handled according to Jewish dietary laws. This certification guarantees that pharmaceutical products, including Active Pharmaceutical Ingredients (API) and finished formulations, adhere to Kosher standards, avoiding the use of non-Kosher substances and ensuring meticulous hygienic practices.
By obtaining a Kosher certificate, pharmaceutical companies can access a broader market, including consumers who require Kosher-compliant medications and health supplements. It demonstrates a commitment to quality and safety, aligning with global standards and fostering trust among Jewish consumers worldwide.
US Drug Master File (USDMF)
A US Drug Master File (USDMF) is a confidential document submitted to the U.S. Food and Drug Administration (FDA) that provides detailed information about the manufacturing process of an Active Pharmaceutical Ingredient (API) or a finished pharmaceutical product. This document includes comprehensive details such as chemical properties, manufacturing facilities, production processes, packaging specifications, storage conditions, and more.
The USDMF ensures that proprietary information remains protected while allowing the FDA to review the data as part of drug approval processes. Unlike other types of DMFs used in different regions, the USDMF is specifically designed to meet the regulatory requirements set by the FDA, ensuring compliance with U.S. standards.
Written Confirmation
When an API is imported into the European Union from elsewhere in the world, it should be accompanied by a “written confirmation” (WC). A written confirmation is a document set up by the health authorities of the country where the API was manufactured. After inspections were successfully performed under EU/GMP equivalent standards, the health authorities can provide a WC. These inspections will also have to regularly take place in the future.
Dirithromycin is a type of Macrolides
Macrolides are a significant subcategory of pharmaceutical active pharmaceutical ingredients (APIs) that are widely used in the healthcare industry. These compounds belong to a class of antibiotics characterized by a large macrocyclic lactone ring, which is the key structural feature responsible for their therapeutic activity.
Macrolides possess a broad spectrum of activity against various bacteria, making them valuable in the treatment of many bacterial infections. They work by inhibiting the synthesis of bacterial proteins, thereby preventing their growth and replication. This mechanism of action makes macrolides effective against both Gram-positive and some Gram-negative bacteria.
One of the most well-known macrolide antibiotics is erythromycin, which has been used for decades to treat respiratory tract infections, skin infections, and sexually transmitted diseases. Over time, several derivatives and semi-synthetic macrolides have been developed, such as azithromycin and clarithromycin, which offer improved pharmacokinetic properties, increased efficacy, and broader spectrum of activity.
Macrolides are often preferred in clinical practice due to their favorable pharmacokinetics, including high tissue penetration, prolonged half-life, and low toxicity. They are commonly prescribed for patients who are allergic to penicillin or have other contraindications to beta-lactam antibiotics.
In conclusion, macrolides represent a vital subclass of pharmaceutical APIs with potent antibacterial properties. Their broad spectrum of activity, favorable pharmacokinetic profile, and versatility make them indispensable in the treatment of various bacterial infections.
Dirithromycin (Macrolides), classified under Antibacterials
Antibacterials, a category of pharmaceutical active pharmaceutical ingredients (APIs), play a crucial role in combating bacterial infections. These APIs are chemical compounds that target and inhibit the growth or kill bacteria, helping to eliminate harmful bacterial pathogens from the body.
Antibacterials are essential for the treatment of various bacterial infections, including respiratory tract infections, urinary tract infections, skin and soft tissue infections, and more. They are commonly prescribed by healthcare professionals to combat both mild and severe bacterial infections.
Within the category of antibacterials, there are different classes and subclasses of APIs, each with distinct mechanisms of action and target bacteria. Some commonly used antibacterials include penicillins, cephalosporins, tetracyclines, macrolides, and fluoroquinolones. These APIs work by interfering with various aspects of bacterial cellular processes, such as cell wall synthesis, protein synthesis, DNA replication, or enzyme activity.
The development and production of antibacterial APIs require stringent quality control measures to ensure their safety, efficacy, and purity. Pharmaceutical manufacturers must adhere to Good Manufacturing Practices (GMP) and follow rigorous testing protocols to guarantee the quality and consistency of these APIs.
As bacterial resistance to antibiotics continues to be a significant concern, ongoing research and development efforts aim to discover and develop new antibacterial APIs. The evolution of antibacterials plays a crucial role in combating emerging bacterial strains and ensuring effective treatment options for infectious diseases.
In summary, antibacterials are a vital category of pharmaceutical APIs used to treat bacterial infections. They are designed to inhibit or kill bacteria, and their development requires strict adherence to quality control standards. By continually advancing research in this field, scientists and pharmaceutical companies can contribute to the ongoing battle against bacterial infections.
