Quality
Ranitidine-HCl Quality(A) Ranitidine Hydrochloride manufactured have following unique characteristics :1) Better whiteness (Abs C 0.1) 2) Low toxicity (Ranitidine free from Methanol, MIBK & Toluene) 3) High Stability (Shelf life of 5 years) 4) Physical properties (Available as required by the end user) (B) Regular Grades of Ranitidine Hydrochloride manufactured:1) Crystalline Powder (80#, Tap density 0.45 to 0.65 gm/ml) 2) DC Grade – Granular Powder (30#, Tap density 0.65 to 0.85) (C) Available in the following pharmacopeia:1) USP – 32 2) EP – 6.0 3) BP – 2009 4) IP – 2007 (D) Regulatory approvals available:1) WHO – GMP 2) EDQM – COS (CEP 2007 – 320) (E) Plant compliant with:1) USFDA 2) ICH Q7 GMP
QUALITY CONTROL & QUALITY ASSURANCE
ORCHEV performs a promising growth through its separate state-of-the-art Quality Control Department, the systems and activities of different departments, conducts internal audits and training programme. It assures the quality of the product dispatched from the manufacturing activities. The QC department has been clearly instructed to make no compromise whatsoever, either in the procurement of raw materials, or in the final output. Besides, QC Department not just informs about the specifications of the product, but also provides valuable contribution in enabling production of high quality product with maximum yield.
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