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Regulatory Approval

Auro Laboratories Secures EDQM Approval for Metformin Hydrochloride Facility at Tarapur

Auro Laboratories has received a formal Attestation of Inspection from the European Directorate for the Quality of Medicines & Healthcare (EDQM) for its MIDC Tarapur facility. This regulatory milestone confirms the site's compliance with European Union Good Manufacturing Practice (GMP) standards for the production of Metformin Hydrochloride.

Three female workers inspecting rolled towels at a textile factory, showcasing teamwork and quality control. Stock photo illustrating Auro Laboratories' regulatory approval story.
Photo: EqualStock IN / Pexels
Key numbers
Market Cap ₹155.22 CrSmall Cap
Revenue TTM ₹28.4 CrOperating Revenue
Net Profit TTM ₹2.96 CrTrailing 12 Months
RSI 42.7Neutral Zone
Order fromEuropean Directorate for the Quality of Medicines & Healthcare (EDQM)

Key highlights

  • Received Attestation of Inspection from the EDQM for the MIDC Tarapur manufacturing unit
  • Certification covers Metformin Hydrochloride under CEP Dossier No. CEP 2005-123
  • Confirms full compliance with Good Manufacturing Practice (GMP) requirements under EU Rules
  • Inspection reference number INSP 2012-002-P05 validates facility quality standards
  • Quarterly net profit growth reached 3727.06% YoY following recent operational improvements

What Approval Was Received?

Auro Laboratories has received a formal Attestation of Inspection from the European Directorate for the Quality of Medicines & Healthcare (EDQM). This approval pertains to the company's manufacturing facility situated at MIDC Tarapur, Maharashtra, and specifically covers the production of Metformin Hydrochloride under CEP Dossier No. CEP 2005-123.

The inspection, reference number INSP 2012-002-P05, confirms that the facility adheres to the Good Manufacturing Practice (GMP) standards mandated by European Union regulations. This certification acts as a critical validation of the company's internal quality controls and its ability to meet the high manufacturing standards required for the European pharmaceutical market.

Why This Approval Matters

  • Facilitates seamless entry of Metformin Hydrochloride into the strictly regulated European pharmaceutical markets
  • Validates the facility's adherence to international quality standards, enhancing the company's reputation among global generic buyers
  • Ensures continuity of supply for existing European clients who require strictly compliant API sources
  • Provides a competitive advantage in the anti-diabetic segment where Metformin remains a first-line treatment globally
  • Reduces regulatory friction for future product registrations leveraging the same audited manufacturing infrastructure

Business Overview

Auro Laboratories Limited is an Indian pharmaceutical company primarily engaged in the manufacturing of Active Pharmaceutical Ingredients (APIs) and intermediates. The company’s core competency lies in the anti-diabetic therapeutic segment, specifically as a leading producer of Metformin Hydrochloride. Operating from its manufacturing facility in MIDC Tarapur, Maharashtra, the company caters to both domestic pharmaceutical players and international export markets.

Its product range also includes various bulk drugs such as Glibenclamide and Metoprolol. By securing international regulatory certifications, the company continues to focus on high-volume generic molecules that require stringent quality compliance for global distribution.

Financial Context

Auro Laboratories reports a trailing twelve-month operating revenue of ₹28.4 crore and a net profit of ₹2.96 crore. The company's recent quarterly performance has shown significant recovery, with revenue growing 207.49% year-on-year and net profit surging by over 3,000% from a low base. Currently, the stock trades at a price-to-earnings (P/E) ratio of 52.51, compared to a sector average of 40.81.

With a market capitalization of ₹155.22 crore and a Piotroski score of 5, the company maintains a stable financial position while benefiting from an operating profit margin of 43.28% in the latest quarter.

Auro Laboratories · share price, past month
Auro Laboratories · financial snapshot
Share price₹249.05
Market capitalisation₹155.22 Cr
Revenue (annual)₹19.40 Cr
Net profit (annual)₹1.84 Cr
Revenue (latest quarter)₹9.39 Cr+6.30% vs previous quarter
Net profit (latest quarter)₹1.95 Cr+172.71% vs previous quarter
P/E (TTM)52.51×Sector 40.81×
Promoter holding52.18%0.00% QoQ
FII holding0%Current quarter

Reference market data from a third-party provider, as of the story. Not a valuation or a recommendation.

Source verified

Exchange filing by Auro Laboratories Limited announcing the receipt of an Attestation of Inspection from the EDQM. Market figures from a third-party data provider.

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