Lumefantrine IP USP: A Critical Antimalarial API in Modern Therapy

  a reputable Indian manufacturer.

Lumefantrine IP USP (lumefantrine) is a synthetic antimalarial compound that has been widely used in developed countries as an adjunctive therapy for the treatment of uncomplicated falciparum malaria. It is a member of the aryl amino alcohol class of compounds, has a long half-life and provides a means to prevent relapses when used in combination with rapidly acting antimalarial products.

As an active pharmaceutical ingredient, lumefantrine is produced under strict standards of the IP and USP pharmacopeia. Both grades provide for the establishment of stringent specifications for purity, identification, assay and impurity limits. These specifications ensure that all lumefantrine products have consistent quality across the world.

Chemical Profile for Lumefantrine

Lumefantrine exhibits the following characteristics from a pharmaceutical aspect:

It has an extremely lipophilic nature.

It does not dissolve in water very well.

Under the appropriate storage conditions, Lumefantrine is stable.

The above property characteristics have an impact on the formulation design, bioavailability and packaging of Lumefantrine. Due to the chemical profile, Lumefantrine has higher efficacy when formulated with other antimalarial drugs that work together with Lumefantrine to increase absorption and ultimately the benefit of treatment.

The Role of Lumefantrine as an Anti-Malarial Drug

Lumefantrine has become a key component in the malaria treatment regimens of modern society. It is a major component of artemisinin-based combination therapies (ACTs); they have been designated by health authorities around the world as the first-line treatments for malaria.

As an anti-malarial API, Lumefantrine functions by preventing the growth of a malaria parasite within a red blood cell through an interference of its metabolic function. The extended duration of action from Lumefantrine will remove any residual effects of the parasite after the quick reduction provided by companion drugs. This combination will decrease the potential of developing resistance and result in improved treatment outcomes.

Pharmaceutical clients must know what differentiates an IP grade versus a USP grade.

Lumefantrine IP USP (Grade - IP)

This grade of lumefantrine is produced in accordance with the specifications of the Indian Pharmacopoeia, which is used throughout Asia and Africa and in many clusters of countries where pharmacopoeial standards are in use.

Lumefantrine IP USP (Grade - USP)

This grade of lumefantrine is produced according to the standards of the United States Pharmacopeia, which for many pharmaceutical manufacturers is critical to the export market and very tightly regulated.

While both grades maintain an extremely high level of quality, there are many factors that can create a difference between these grades: testing methods, impurity profiles, and documentation methods. The most reliable manufacturers will have a working relationship with their suppliers and meet the best standards of both grades for effective global distribution of their products.

The process of making the active ingredient (API) of Lumefantrine is controlled and includes several required steps of chemical reactions. Each step of making Lumefantrine API will be monitored to make sure it can be made consistently, safely and in compliance with local or federal regulations.

The following is a list of the main components of the manufacturing process for pharm. APIs:

* Controlled sourcing of materials

* Validated processes for synthesizing and purifying APIs

* Quality checks during production

* Identity, assay, impurities and stability testing at the end of the manufacturing process

Manufacturers must implement strict quality control systems in order to produce API bulk drugs that meet both the Pharmascope's pharmacopeial standards and the expectations of customer. In addition, manufacturers must keep accurate batch records and traceability through the entire production process.

Regulatory Compliance: IP, USP, GMP, and WHO-GMP

Regulatory compliance is one of the most important factors in determining whether or not an API will be accepted globally. It is critical for reputable manufacturers to ensure their manufacturing processes are compliant with the following:

1. Indian Pharmacopoeia (IP)

2. United States Pharmacopeia (USP)

3. Good Manufacturing Practices (GMP)

4. WHO-GMP

These four regulatory frameworks ensure that products are safe, consistent and appropriate for international distribution. As a result, more and more buyers are choosing suppliers who provide assistance with audits, regulatory submissions, and long-term supply agreements.

Lumefantrine rarely functions as a standalone product. Instead, many [merchant-] formulators, including the healthcare community and their procurement agents, are primarily using Lumefantrine to create fixed-dose combination products with Fast-Acting Antimalarial agents. This is a positive development in terms of success rates for malaria treatment and in line with global malaria control strategies.

India will continue to play a crucial role in delivering active pharmaceutical ingredients to countries across Africa, Southeast Asia, and parts of Latin America. With its extensive manufacturing capability and technical knowledge of regulatory compliance throughout regulated and semi-regulated markets, Indian suppliers are uniquely positioned to supply both types of markets in an efficient manner.

Sourcing From A Trusted Manufacturer Of APIs, India

Pharmaceutical companies must select a supplier of APIs from India with great care. Selecting a reliable supplier who manufactures in India will provide pharmaceutical manufacturers with the following benefits:

1. Consistent quality, & batch-to-batch consistency

2. Competitive pricing on bulk supply of APIs

3. Strong Regulatory Support (Documentation)

4. Flexibility in the scale of manufacture and the ability to export

As an example of this, companies like Prism Industries Private Limited, who emphasize quality driven manufacturing have established India as a leading supplier of the active pharmaceutical ingredients for Lumefantrine and other antimalarial treatment products.

Storage, Stability, and Packaging Requirements for Lumefantrine

To keep Lumefantrine IP USP in optimum condition, it should be:

- Stored in a cool and dry place

- Kept away from direct sunlight and moisture

- Properly closed in stable and impotent containers that the manufacturer has recommended storage conditions for the products during their shelf-life.

Conclusion

Lumefantrine (IP USP-) will serve as a base case for future malaria medications. It has shown to provide effective treatment for malaria, and it is included in all pharmaceutical compendia throughout the world.

The continued increasing need for lumefantrine P-qualifying will require partnership with an Indian API manufacturer who is committed to providing high quality and long-lasting service. Additionally, pharmaceutical manufacturers will have confidence that, by using an Indian API manufacturer, they have secured the long-term reliability of their supply chain, as well as the compliance with the applicable regulatory authorities.