Excipients & Solvents for the Pharma Industry
Rchem, is a leading manufacturer and supplier of critical and regulated raw materials, performance ingredients to serve the Life Science industry. For additional information, please visit www.Rchem.com. At Rchem, we take pride in our comprehensive portfolio of novel excipients and solvents. We constantly innovate and apply the latest technologies in manufacturing products that serve the pharma and healthcare industry for various pharmaceutical formulations.
We understand the need for perfection in the quality of all products and are committed to achieving this precision in analysis. Our customers are assured of receiving zero fault goods, as at Finar, every stage of production from vendor approval of raw materials to production and post-production is closely monitored as per specifications.Each of the manufacturing and quality processes is mapped and recorded as per ISO 9001 standards.
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 grade 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