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 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 34
2) EP 7.0
3) BP 2011
4) IP 2007

(D) Regulatory approvals available:


1) WHO GMP
2) EDQM - COS (CEP 2007 / 320)
3) Korean Food and Drug Administration (KFDA)
4) COFEPRIS - Mexican Health Authority
5) Written Confirmation for EU
6) Ranitidine registered with RUSSIAN - State registration of medicinal products
7) ISO 9001:2008 issued by TUV SUD
8) DMF filed with TPD - Canada


(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.

The QA department is proficient in all the aspects of system designing and maintenance needed for a cGMP facility.

The QA/QC team is lead by a group of talented professionals.