Actylis
Excipients & Solvents for the Pharma Industry
RikiGlobal Trading Pvt Ltd has partnered with Actylis, a distinguished name in the pharmaceutical industry renowned for its innovative and comprehensive portfolio of excipients and solvents. Actylis's dedication to enhancing the pharmaceutical and healthcare sectors aligns with our commitment to bring only the best and most reliable products to our clients.
About Actylis
Actylis stands out in the pharmaceutical industry for its pioneering efforts in developing a wide range of novel excipients and solvents. Their dedication to innovation is backed by the application of the latest technologies in manufacturing products that are crucial for various pharmaceutical formulations.
State-of-the-Art Manufacturing
Actylis’s manufacturing capabilities are impressive, boasting a GMP-certified plant that produces over 100 types of excipients and novel solvents. These products are essential for the development of future generic formulations, including oral solids and semi-solids, injectables, topical, and derma applications. Notably, Actylis also specializes in manufacturing special excipients for oncology and DMF-filed excipients with regulatory approvals in the US and China.
Global Reach and Certification
Our partnership with Actylis allows us to offer products that are recognized and used by the top pharmaceutical companies in India and over 200 customers worldwide. Actylis's commitment to quality is further evidenced by their EXCiPACT certification, ensuring compliance with global standards and processes.
Quality Assurance and Regulatory Compliance
Actylis’s Quality Assurance team is proactive in adhering to guidance from various regulatory bodies, staying abreast of all the latest recommendations. They provide all necessary declarations and documentation support, enabling our clients to qualify for their audits successfully.
Our excipient and solvent offerings are as per the following categories
All these products are manufactured in our revised Schedule M certified facility and are offered with complete regulatory support & documentation as under
- 3 Batch Samples for Validations & Approvals
- Residual Solvent Compliance
- Elemental Impurities Compliance
- Genotoxic Impurities Compliance
- TSE / BSE free Certificate
- Nitrosamine Impurities Compliance
- GMO Declaration
- GMP, EXCiPACT and IMS Certificate
- Stability Data & Shelf Life Declaration
- Latex / Gluten / Melamine / Allergen free Declaration
- Products offered for R&D, Exhibit levels as well as Commercial Scale Manufacturing
- Pack Mode Declaration
- LOA for DMF Drade Products
- Manufacturing Flow Chart
- Site Plan & Organogram
- Specifications, Method of Analysis and COA
- Supporting Chromatograms
- Method validation Report
- Batch Number Nomenclature
- CTD Dossier Preparation , US DMF and China DMF Filing Support
- Vendor Qualification Questionnaire & Subsequent Plant Audit