Consistently Meeting Global Regulatory Standards

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Quality & Regulatory

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

SKPL’s 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.

SKPL 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.


Certifications Year(s) Facility Products
US FDA 2007, 2011 Unit I Acetaminophen
2007, 2011 Unit II Acetaminophen Granules DC
2011 Unit III Folic Acid API
TGA 2004, 2010 Unit I Acetaminophen (Paracetamol)
2004, 2007 Unit II GMP Compliance
German Regulatory 2011, 2014 Unit II Acetaminophen (Paracetamol) & Perindopril Granules
ISO9001:2008 (AQA) 2012 Unit II QMS Compliance
WHO GMP 2009, 2012, 2014 Unit I Acetaminophen (Paracetamol), Domperidone & Dompweidone Maleate
2010, 2013 Unit II GMP compliance
AFSSAPS 2006 Unit I Acetaminophen (Paracetamol), Domperidone Maleate
COFEPRIS 2014 Unit I Acetaminophen (Paracetamol), Domperidone & Domperidone Maleate
2014 Unit II GMP compliance
AIFA 2007 Unit I Domperidone
2008, 2012 Unit II GMP compliance


The following products are covered under CEP/ COS from EDQM

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