Manufacturing

Facilities

Our associated state-of-the-art manufacturing facilities are located in Ahmedabad. The pharmaceutical facilities are WHO-GMP approved and are built as per EU GMP guidelines. Our associated Nutraceutical facilities have various certifications, including WHO GMP, FSSAI, Halal, HACCP, and Kosher, and cater to both domestic and international markets. These facilities are designed, constructed, and maintained according to the latest cGMP norms.

Quality Assurance

We strive to provide customers with quality products that exceed their expectations. We achieve this through our Quality Assurance program, developed to ensure continuous validation and improvement in all areas of the manufacturing process. The depth of experience, capabilities, and knowledge of our manufacturing units’ technical professionals, combined with advanced scientific analytical instruments, ensures world-class quality in the final product.

To ensure world-class quality of final products, our manufacturing units have strictly implemented the following:

• Calibration and validation of equipment
• Control of inputs, API, intermediates, excipients, and packing material
• Accelerated and real-time stability studies
• Complete in-process testing
• Close monitoring of product quality throughout its shelf life
• Training and documentation inspection
• Internal and external auditing

Regulatory Affairs

The depth of experience, capabilities, and knowledge of our technical professionals, combined with strong scientific data, enables us to compile CTD files in line with international requirements, as well as in specific patterns requested by the MOH.

Our team consists of pharmacists and technical experts proficient in:

• Preparing the CTD/ACTD files and product dossiers as per MOH guidelines
• Coordinating with the FDA and WHO for various certifications
• Legalizing documents with embassies
• Resolving technical queries with authentic in-depth data

Pharmacovigilance

All of our products are evaluated before marketing authorization. However, some risks may only become apparent after the product is on the market and in widespread use. Prompt reporting of any adverse reaction is the best way to identify and investigate potential issues.

To report an adverse event, email: info@www.zyonis.com