Health Canada rigorously inspected Neova Technologies Inc. (NTI)
In August 2018, Health Canada rigorously inspected Neova Technologies Inc. (NTI), a subsidiary of the Bioseutica® Group. This critical evaluation was designed to ensure NTI's operations comply with the stringent requirements outlined in the Canadian Food and Drug Act and its associated regulations. After this inspection, NTI was awarded a compliance rating, indicating that its activities met all the regulatory standards.
The Canadian Food and Drug Act and its accompanying regulations set comprehensive guidelines for the manufacturing, packaging, labeling, and testing of pharmaceutical products. Compliance with these regulations is essential for any company producing Active Pharmaceutical Ingredients (APIs). These guidelines ensure all products are manufactured to the highest safety and efficacy standards, assuring regulatory bodies and consumers.
Due to the successful inspection, NTI received its Establishment License. This license authorizes the company to manufacture, package, label, and test non-sterile Active Pharmaceutical Ingredients (APIs), specifically focusing on Trypsin. Trypsin is a crucial enzyme used in various applications across multiple industries, including food, diagnostics, healthcare, and animal feed.
Neova Technologies Inc. is renowned for producing high-quality pancreatic enzymes, such as trypsin, chymotrypsin, and phospholipase A2. These enzymes play vital roles in several applications. For instance, they produce infant formulas requiring precise enzymatic activity to ensure proper infant nutrition. Additionally, these enzymes are integral to tissue and cell biology, aiding in cell structure and function studies. They are also used in producing vaccines, where enzymes are necessary for processing and purification steps, and in pharmaceutical applications, where they serve as active ingredients.
The Bioseutica® Group, to which NTI belongs, is a global leader in the pharmaceutical market, mainly known for producing egg lysozyme, protein, and pancreatic enzymes. Bioseutica®'s innovative approach to natural proteins and enzymes has established the company as the preferred choice across the food, feed, and pharmaceutical sectors. Their products are celebrated for their high quality, reliability, and effectiveness, making them indispensable in various industrial applications.
Bioseutica®'s dominance in the market is a testament to its commitment to innovation and excellence. Its egg lysozyme, for example, is widely used as a natural preservative due to its antibacterial properties. Similarly, its egg protein products are highly valued in the food industry for their nutritional benefits. The pancreatic enzymes produced by Bioseutica® are crucial in both the pharmaceutical and healthcare industries, where they are used in drug formulations and diagnostic procedures.
The inspection by Health Canada and the subsequent receipt of the Establishment License highlight NTI's dedication to maintaining high quality and regulatory compliance standards. This achievement ensures that NTI can continue to provide reliable and safe APIs to its customers, further solidifying its reputation in the industry.
Furthermore, NTI's success reflects the broader mission of the Bioseutica® Group to lead the market through innovation and quality. By consistently meeting and exceeding regulatory requirements, Bioseutica® and its subsidiaries like NTI demonstrate their commitment to advancing the fields of food, diagnostics, healthcare, and feed industries.
In conclusion, the August 2018 inspection by Health Canada confirmed that Neova Technologies Inc. (NTI) complies with the Canadian Food and Drug Act and its associated regulations. This compliance allowed NTI to obtain its Establishment License, enabling the company to manufacture, package, label, and test non-sterile Active Pharmaceutical Ingredients (APIs) such as Trypsin. NTI's production of pancreatic enzymes for various industries underscores its critical role in providing high-quality, innovative products. As part of the Bioseutica® Group, NTI contributes to the company's global leadership in the natural proteins and enzymes market, consistently delivering products that are the first choice for the food, feed, and pharmaceutical sectors.