Quality
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  • Having a firm focus on the Pharma industry, quality and stringent control has been our top-most priority. We have created a resource that matches the exacting US FDA requirements and addresses the increasingly demanding needs of the modern health care industry.
  • We are committed to a programme of continuous quality improvement in order to meet the requirements of customers, regulatory bodies, associates as well as the environment. This imposes a responsibility of recognizing the real needs of customers and ensuring compliance at every level, again and again.

Quality Policy
We are committed to manufacture the packaging materials of right quality at right time to the customer satisfaction. We endeavor to continually improve the quality management systems to delight customers by providing assurance on product quality.

M. Madan Mohan Reddy
Managing Director

cGMPs
All manufacturing facilities and our policies and procedures are governed by current Good Manufacturing Practices(cGMPs). These are formally audited regularly during the year and all issues that may arise are closed out through corrective and preventive action measures (CAPA).
The documentation that is available with us is in line with cGMP requirements as applicable in Pharmaceutical industry and has been audited and certified by several leading finished formulation pharmaceutical companies.
All our personnel are thoroughly trained on various aspects of cGMP on a continuous basis to make them constantly aware of cGMP requirements and update if needed.

Drug Master File
Our Drug Master File, maintained with the FDA in USA contains all product specifications, quality requirements, product drawings, USP test results and all other relevant technical information.

Certification Programs
We were ISO 9001 certified in year 2006 and have a DMF with US FDA since 2006. We also have certified as DS/EN ISO: 15378: Primary Packaging Materials for Medicinal Products.
We have been audited and approved by several domestic and international pharmaceutical companies. Many of them have awarded us "Approved Vendor" status in recognition of our facility as per cGMP norms, product quality and reliable services.

USP Tests
All drug containers manufactured by us are in compliance with standards set by the United States Pharmacopoeia, section <661>. Additionally, we have on file USP <661> test results for more than 50 different bottles as filed in our DMF.

LOT Traceability
We use raw materials for all molding applications only from DMF source through long term arrangements with manufactures to ensure an uninterrupted supply.
Our cGMP manufacturing environment and adherence to carefully developed procedures assure our customers 100% lot traceability.
We ensure "traceability" up to last hour of production - enabling us to identify the date and time of manufacturing of each carton. This information is maintained in our Quality Assurance Department along with samples.

Accreditations

  • DMF with USFDA
  • DS/EN ISO: 15378
  • ISO 9001: 2008 by NQA
  • Complying with cGMP norms
  • Well Equipped Q.C. Laboratory