An Active Pharmaceutical Ingredient (API) refers to the main component of a medication that provides its therapeutic effect. It is a substance or combination of substances present in medicine to elicit a pharmacological response.
For instance, a pain-relieving API is present in painkillers. Only a tiny quantity of the API is required to produce a function for the intent of the medicine. The name and amount of the API used in OTC (over-the-counter) drugs are on their packaging.
How Is API Manufactured?
API and raw materials are confused, but they have distinct meanings.
Raw material refers to chemical compounds that are the foundation for creating an API. As a rivaroxaban manufacturer, we utilize cutting-edge technology in our plant to manufacture the API from the raw materials.
The transformation from raw material to API involves several chemical compounds and intermediates. Intermediatesare chemical compounds in the process of transitioning from a primary matter to an API.
What Considerations Do We Follow While Manufacturing APIs?
- As one of the top CDMO companies in India, our first step is to research and develop a method for creating the chemical compound that will become the API in the laboratory.
- We determine the appropriate concentration and temperature to manufacture a high-quality API.
- To ensure the API’s purity, the quality control staff conducts rigorous testing in our laboratory. Finally, our quality assurance staff confirms the entire manufacturing process, from API production to quality testing.
Thus, the API production process involves personnel to guarantee a successful outcome.
4 Reasons Pinnacle Is A Leading Pharma Contract Manufacturers In India For APIs
1. Active Research
Pinnacle’s primary objective is to actively participate in research and development activities that enhance people’s quality of life. As CDMO pharma companies in India, we prioritize customer satisfaction by constantly upgrading our technology, adhering to high business ethics, and developing new products. Therefore, we allocate a significant portion of our revenue towards intensive research and development to achieve breakthroughs in formulation development. To meet the growing demand for innovative dosage forms, we have assembled a team of expert formulation scientists and equipped them with modern facilities and equipment to develop and improve formulation technologies.
2. State-of-the-art Research and Development
Pinnacle has established a state-of-the-art facility in Baddi, certified by the World Health Organization for its adherence to good manufacturing practices (WHO GMP). Quality is vital to the company, and several countries, such as Tanzania, Ethiopia, Kenya, and Sri Lanka, have approved Pinnacle’s manufacturing facilities. The Research and Development team of PLS specializes in complex generic formulations. Additionally, being renowned CDMO pharma companies in India, we take responsibility for transferring the technology for the formulation from our Research and Development facility to the preferred manufacturing partner or the client’s manufacturing site.
3. Significant Annual Production Capacity
With over 400 clients, 90+ countries to export to, production of 3 billion units of tablets, and 300 million units of capsules, Pinnacle is always a step ahead in orders. Becoming one of the top CDMO companies in India requires perseverance and consistency. The dedication has allowed us to deliver consistently and pushed us to significant annual production capacity.
4. Potent Products
Our business has experienced remarkable growth due to our strategic approach, allowing us to surpass our initial expectations. We ventured into exports at an early stage, and since then, we have captured a significant share of the global market as a rivaroxaban manufacturer. We export our products to more than 40 countries and expand to serve more clients. Our goal is to extend our presence to over 80 countries by 2025.
Conclusion
APIs are crucial for activating the desired function of the medicine. In other words, APIs are medicine catalysts. Since APIs are present in the drug in small quantities, their preparation is technical and requires an analytical approach.
Pinnacle Life Science, a pharma contract manufacturer in India, has established itself as a leading contract development and manufacturing organization (CDMO). Our success is due to our unwavering focus on quality and service, rooted in our commitment to innovation. Our team focuses on exact quantities and proper formulations to manufacture the best for a healthy world.
Learn more about our API manufacturing practices.
