Infrastructure

The total built up space of the facility is around 15,200 square feet. The total manufacturing capacity is a combination of FLUID BED COATERS, RMG, EXTRUDER, SPHERONIZER, BLENDER AND TRAY DRYER procured from some of the leading machine manufacturers in the industry. The overall capacity stands at more than two hundred metric tons annually and the plans for further expansion is already in place. The upcoming expansion is a combination of both PFFI'S & FDF'S giving us the scope in filing the dossiers in markets including EUROPE, UK AND USA. A dedicated manufacturing line is allocated for products like Pancreatin where the source is derived from animals

The Quality systems at APIGRAN adhere to 21 CFR PART 11 compliance guidelines. With a strong emphasis on quality, the company has established a robust quality control system to meet regulatory requirements and maintain product integrity.We maintain well-equipped, modern quality control laboratories staffed by highly skilled professionals. These laboratories are equipped with cutting-edge instrumentation and technologies, enabling accurate and comprehensive analysis of raw materials, in-process samples, and finished products.

By staying up-to-date with evolving regulations, APIGRAN PHARMA ensures compliance and consistently delivers products of the highest quality. The quality control system incorporates a comprehensive testing and analysis approach. It encompasses the sampling and testing of raw materials, packaging materials and finished products at various stages of the manufacturing process. Through rigorous testing, the company evaluates critical quality attributes, including identity, purity, potency, dissolution, and stability, to guarantee product safety and efficacy.

Robust Documentation and Record-Keeping:

APIGRAN PHARMA places significant emphasis on meticulous documentation and record-keeping practices. Standard Operating Procedures (SOPs) are developed and implemented for each quality control process, ensuring consistent and standardized testing methodologies. The company maintains comprehensive records of all tests, results, equipment calibration, and any deviations or corrective actions taken. This documentation enables traceability and facilitates thorough review and audits.

Continuous Improvement and Innovation:

We foster a culture of continuous improvement and innovation within its quality control system. The company actively seeks advancements in analytical methodologies, adopts emerging technologies, and incorporates best practices to enhance the accuracy, efficiency, and reliability of its testing processes. By staying at the forefront of scientific developments, APIGRAN PHARMA ensures that its quality control system remains at the cutting edge

Training and Development:

We recognize the pivotal role of well-trained and competent personnel in maintaining a robust quality control system. The company invests in regular training and development programs for its quality control staff. Training covers areas such as laboratory techniques, safety protocols, regulatory compliance, and quality management principles. This investment in human capital ensures that APIGRAN PHARMA's personnel possess the necessary knowledge and skills to execute their roles effectively.

Collaboration between Quality Control and Other Departments:

We foster strong collaboration between its quality control department and other departments, particularly quality assurance, research and development, and manufacturing. This interdisciplinary collaboration ensures seamless information flow, prompt investigation of any quality-related issues, and timely implementation of corrective and preventive actions. By working together, APIGRAN PHARMA enhances its overall quality control efforts and strengthens the quality culture throughout the organization.

APIGRAN PHARMA's commitment to maintaining a robust quality control system is evident in its stringent adherence to regulatory standards, cutting-edge laboratory infrastructure, comprehensive testing procedures, meticulous documentation, continuous improvement initiatives, and investment in skilled personnel