JRS PHARMA announced the JRS Pharma LP sites in Cedar Rapids, Iowa were awarded an EXCiPACT Certificate from SGS for the production of Microcrystalline Cellulose, Silicified Microcrystalline Cellulose, and Dextrates as well as Good Distribution Practice for the central logistics warehouse.
This document demonstrates that JRS Pharma LP manufactures and distributes according to the EXCiPACT Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) Certification Standard. The certificate helps drug manufacturers to reduce efforts and costs as they need to either audit new suppliers themselves or commission 3rd party physical audits to demonstrate GMP and GDP compliance.
JRS PHARMA's line of Microcrystalline Cellulose products manufactured at the Cedar Rapids facility include a graduated product portfolio with different grades of VIVAPUR®, EMCOCEL®, UNITAB®, HEWETEN®, and FLOCEL®, designed for specific formulation needs. MCC is an odorless, tasteless, white powder with a high degree of brightness, derived from highly purified wood pulp. With a wide range of chemical, technical, and economic benefits, MCC is one of the most widely used binder excipients for solid dosage forms.
The EXCiPACT certification covers PROSOLV® SMCC, a High Functionality Excipient based on Microcrystalline Cellulose, produced at JRS PHARMA’s Cedar Rapids site. JRS PHARMA’s portfolio includes many different grades of PROSOLV® SMCC to provide solutions to various formulation challenges.
Also covered by the EXCiPACT certification are EMDEX®, and CANDEX® dextrates, which are directly compressible, 100% water soluble, and lactose-free tablet binders. It is composed of a unique combination of glucose monohydrate and different polysaccharides derived from starch manufactured by JRS Pharma in Cedar Rapids.