Albendazole is an oral medication that treats several kinds of parasitic infections. It is available as both a brand-name drug (Albenza) and a generic version. The generic is considered just as safe and effective as the brand-name drug, and it costs less.
The FDA maintains an NDC directory that lists information on all finished compounded human drugs and unfinished pharmaceutical drug substances that contain Albendazole API. Click here to find a list of Albendazole supplier with NDC on pharma compass.
GMP Certified Manufacturing Facility
A GMP certified manufacturing facility is a guarantee that your pharmaceutical products are produced in a controlled and clean environment. This certification is an international standard that ensures quality and safety for patients and consumers around the world. It also shows the FDA and other regulatory bodies, like the MHRA in the UK, that your company is committed to high standards. A GMP certified manufacturer also has a more positive reputation with other companies, which makes them more likely to get business from those looking for reliable manufacturers.
GMP stands for good manufacturing practices, and it encompasses all of the policies and systems medical production facilities go through to ensure their products meet quality standards. These include everything from obtaining adequate quality raw materials, cleaning the facility and equipment, and training staff. It also requires the establishment of robust procedures, inspections of those processes, and documentation of all steps. The goal of a GMP certification is to minimize the risks involved in pharmaceutical production that cannot be eliminated through testing the finished product.
The GMP facility at Mayne Pharma is a multi-functional, state-of-the-art laboratory equipped to support small pre-clinical and clinical trials and full commercial manufacture. The facility has extensive capabilities including formulation development and analysis, cGMP-compliant small molecule synthesis, advanced intermediates, chemical process development and optimization and analytical method development.
Whether you need to develop a new drug or want to produce generics, the best way to do it is in a cGMP-certified facility. A cGMP-certified facility has strict manufacturing guidelines and is regularly inspected by an FDA-accredited inspector. It is also capable of developing complex drug delivery systems, assisting with NDAs, 505(b)(2) and ANDAs.
A GMP-certified facility must have a solid team of experts in order to maintain the highest level of standards. The team should be able to identify potential problems and respond quickly. This will help reduce the number of incidents that lead to recalls and other serious issues. It should also be able to provide detailed reports on the results of those incidents. In addition, the facility should be able to respond to complaints and make necessary changes.
NDC Number
The NDC (National Drug Code) is a unique 10-digit number that serves as the universal product identifier for all drugs. The NDC contains three segments: the labeler code, the product code, and the trade package size. The first segment identifies the labeler, or firm, that manufactures or processes a drug product, and the second segment identifies the specific strength of the drug in milligrams per pill. The third segment identifies the type of package size and type.
The FDA requires that all drug manufacturers and compounders submit their NDCs to the agency. The NDC Directory is updated daily and contains the information submitted by these companies. However, the NDC Directory does not include finished or unfinished prescription drugs, over-the-counter medications, or drugs that are sold as part of a kit or combination product. In addition to the NDC, a drug manufacturer must also submit a Certificate of Analysis.
A Certificate of Analysis (CoA) is a formal document that certifies that a drug meets the specified quality requirements. It is an essential part of the quality control process. Depending on the type of CoA, it may be used to validate the identity of raw materials or to test for compliance with manufacturing specifications.
Benzimidazole is an antiparasitic agent that can be used to treat a wide range of parasitic diseases in humans and animals. It is a broad-spectrum anthelmintic that kills sensitive parasites and prevents new infections by stopping the growth of existing worms. It is also a powerful nematode and tapeworm treatment, and has the highest insecticidal effect of the benzimidazole family.
Choosing the right supplier for Albendazole is critical to ensure that you receive high-quality products at a competitive price. PharmaCompass can help you find the best suppliers by filtering on GMP, FDA, CEP, Written Confirmation and other certificates. Just let us know what your requirements are, such as whether you need a product with a specific monograph like EP (Ph. Eur), USP, JP, BP or another quality. We can also help you determine which companies have the best API price for your needs.
USDMF
Albendazole is used to treat certain tapeworm infections in humans. It is typically prescribed by a doctor or veterinarian and can be found in both generic and brand-name forms. It works by killing sensitive parasites in the body. It is also available in oral tablets, liquids, and injections. A pharmacist can recommend the best dosage for your condition. The recommended dosage varies depending on the type of infection you have and your age.
FDA-registered drug companies can submit a Drug Master File (DMF) for the active ingredient in their products to support regulatory filings with the US Food and Drug Administration (FDA). These submissions may be required for ANDA, export applications, or INDs. A DMF is a confidential document that contains comprehensive information about the manufacture and quality of a drug substance or finished product dosage form. The DMF must be submitted in eCTD format to meet FDA requirements.
The FDA maintains a list of DMF submissions that have passed the completeness assessment and are available for reference by ANDA applicants under GDUFA. The list of DMFs is categorized by type and includes the name, DMF number, and a link to the corresponding DMF website.
In addition to the USDMF, Freyr has a highly skilled and committed Regulatory team that specializes in preparing and managing DMFs for APIs and other drug components. This team is capable of supporting the full spectrum of FDA regulatory activities, from developing a DMF submission to managing a DMF during the review process.
If you are looking for a USDMF, check the company’s website to determine whether it is a legitimate supplier. Also, check the manufacturer’s background and reputation. You should also ask the supplier if they can provide you with written confirmation, which is a requirement for most USDMFs.
In addition to a USDMF, you should also look for an ISO or GMP certification from the manufacturer. This will help ensure the safety and efficacy of your medications. In some cases, the supplier may even offer a sample for testing to prove their competence. You should also consider the manufacturer’s manufacturing capabilities and capacity. This will affect the final price of your medications.
Written Confirmation
The pharmaceutical industry has made significant advancements in antiparasitics. They are now a vital tool in the fight against parasitic infections, benefiting both human and animal health. These advances have led to the development of innovative new products and improved existing ones. This has helped to reduce morbidity and mortality rates, improving both the quality of life for humans and animals. It has also enabled the use of more sophisticated treatment options, reducing toxicity and side effects.
In order to ensure the safety and efficacy of these new treatments, manufacturers must adhere to stringent standards when producing Albendazole APIs. This includes complying with GMP regulations. To do so, they must submit a Written Confirmation (WCO) to the FDA. This document is a key element of the approval process for pharmaceutical companies.
A WCO is a legal document that verifies that the manufacturing facility of an Albendazole supplier meets the regulations of the importing country. This document is required when exporting Albendazole APIs or finished pharmaceutical drugs to another nation. It is also needed for submitting applications to the FDA. A WCO can be issued by the FDA or by a foreign government agency that is recognized by the FDA.
The WCO is a critical part of the API sourcing process, and it’s important to understand its significance. In fact, it can make or break a company’s application to the FDA for a drug license. A recent case of a US-based pharmaceutical company running into regulatory hurdles due to the lack of an approved WCO illustrates how crucial this document is.
The WCO is not a one-size-fits-all piece of paper, and it varies depending on factors like the type of API and the country of origin. However, it’s the cornerstone of effective, transparent API sourcing. It’s vital to stay up-to-date on the latest regulatory changes and understand how they affect the requirements of the Written Confirmation. By staying informed, companies can avoid costly mistakes and streamline the sourcing process. This will allow them to bring groundbreaking treatments to patients faster and more efficiently.
