Sri Krishna Pharma - Trusted partners for life's journey

Quality & Regulatory

Our non-negotiable, non-compromise approach to Quality, is we believe THE reason for the enduring trust and respect we have gained from our customers and partners across the globe.

Overview

We have institutionalised our quality training programs ensuring that everyone from management to front line employees undergo periodical refresher course on quality practices and stay relevant to current industry trends.

While we encourage our employees to innovate and improvise on the job, we conduct regular audits of our processes and systems to make sure that our product(s) quality are par excellence.

Sri Krishna Pharmaceuticals quality charter is as stated in our quality policy, abided by all our employees and partners in everything we do.

Quality Policy

SKPL strives for Market Leadership by supplying quality products consistently to the full satisfaction of its customers in National and Global markets with a commitment of compliance of its products with regulatory and customer requirements.

Sri Krishna Pharmaceuticals is committed to implement and improve the Quality Management System on a continual basis with its established quality objectives understood by all within the organization and their periodical review for a continuing suitability.

This policy is achieved through the well-defined quality objectives.

The visible results of this stringent adherence to quality processes and practices is that our facilities and products have consistently earned the approvals of global regulatory bodies.

Click here to download the full policy.

New QMS system implemented

21 CFR /Annex 11 software for laboratory systems is now used in production systems, quality systems and all documentation in relation to manufacture at our DC and FDF facility at Nacharam. There is a comprehensive maintenance program we have also put in place.

Facilities:

CertificationsYear(s)FacilityProducts
US FDA2007, 2011Unit IAcetaminophen
2007, 2011Unit IIAcetaminophen Granules DC
2011Unit IIIFolic Acid APIn
TGA2004, 2010Unit IAcetaminophen (Paracetamol)
2004, 2007Unit IIGMP Compliance
German Regulatory2011, 2014Unit IIAcetaminophen (Paracetamol) & Perindopril Granules
ISO9001:2008 (AQA)2012Unit IIQMS Compliance
WHO GMP2009, 2012, 2014Unit IAcetaminophen (Paracetamol), Domperidone & Dompweidone Maleate
2010, 2013Unit IIGMP compliance
AFSSAPS2006Unit IAcetaminophen (Paracetamol), Domperidone Maleate
COFEPRIS2014Unit IAcetaminophen (Paracetamol), Domperidone & Domperidone Maleate
2014Unit IIGMP compliance
AIFA2007Unit IDomperidone
2008, 2012Unit IIGMP compliance

Products:

The following products are covered under CEP/ COS from EDQM

- Acetaminophen (Paracetamol)
- Domperidone
- Domperidone Maleate
- Folic Acid
- Enalapril Maleate
- Furosemide
- Glibenclamide