IOL Chemicals secures EDQM certificate for Fenofibrate Process II

1 min read | Published on 25 Sept 2026, 01:36 PM |Updated on 25 Sept 2026, 02:28 PM

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Key Highlights

IOL Chemicals obtained EDQM Certificate of Suitability for Fenofibrate - Process II
Certification granted on September 24, 2026, adding to existing Fenofibrate CEP
Enables supply to regulated markets including Europe
Process II developed to meet specific customer requirements

*this image is generated using AI for illustrative purposes only.

IOL Chemicals & Pharmaceuticals has obtained a Certificate of Suitability (CEP) from the European Directorate for the Quality of Medicines & HealthCare (EDQM) for Fenofibrate - Process II.

The certification was granted on September 24, 2026. This new credential is in addition to the company's existing valid CEP for standard Fenofibrate. The development enhances the company's ability to supply this active pharmaceutical ingredient (API) to regulated markets, particularly in Europe and other jurisdictions recognizing EDQM standards.

Regulatory milestone and market access

The Certificate of Suitability validates that the manufacturing process complies with European Pharmacopoeia standards. By securing a CEP for a distinct process, IOL Chemicals & Pharmaceuticals reinforces its position as a compliant supplier in stringent regulatory environments. The company stated that Process II was developed specifically to cater to the unique requirements of its customers.

Significance for regulated market supply

This approval facilitates the supply of Fenofibrate - Process II in regulated markets. It underscores the company's commitment to maintaining multiple compliant production pathways for key molecules. Fenofibrate is widely used in lipid-regulating therapies, making this expansion critical for meeting diverse customer needs while adhering to strict quality norms.

Detail	Information
Certifying Authority	EDQM (European Directorate for the Quality of Medicines & HealthCare)
Certificate Type	Certificate of Suitability (CEP)
Product	Fenofibrate - Process II
Date of Grant	September 24, 2026
Validity	Subject to continued compliance with EDQM conditions
Relevance	Regulated market supply; additional to existing Fenofibrate CEP

Historical Stock Returns for IOL Chemicals & Pharmaceuticals

1 Day	5 Days	1 Month	6 Months	1 Year	5 Years
-1.76%	+1.23%	+8.00%	+165.67%	+92.27%	+76.30%

How might the addition of Fenofibrate Process II influence IOL Chemicals' pricing power in European markets compared to competitors with single-process certifications?

What specific customer segments or formulation types is Process II targeting that the existing standard process cannot adequately serve?

Could this dual-process capability position IOL Chemicals to capture market share from Indian peers currently facing regulatory scrutiny in Europe?

IOL Chemicals & Pharmaceuticals

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IOL Chemicals secures EU-REACH registration for Triacetin exports

1 min read | Published on 23 Sept 2026, 06:53 PM |Updated on 23 Sept 2026, 06:53 PM

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Ashish TScanX News Team

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Key Highlights

IOL Chemicals secured EU-REACH registration for Triacetin
Certification enables exports to all European Union countries
Approval granted by European Chemicals Agency under REACH framework
Registration supports expanded global market access and compliance

*this image is generated using AI for illustrative purposes only.

IOL Chemicals & Pharmaceuticals has received EU-REACH registration for its product Triacetin, a critical step enabling exports across all European Union countries.

The certification was granted under the Registration, Evaluation, Authorisation and Restriction of Chemicals framework by the European Chemicals Agency. This regulatory approval directly addresses market access barriers, allowing the company to legally distribute Triacetin within the EU region.

Regulatory details

The company filed this disclosure pursuant to Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, and the SEBI Master Circular dated January 30, 2026. The registration is valid in accordance with the applicable provisions of the EU REACH Regulation, subject to continued compliance with regulatory requirements.

Particulars	Details
Regulatory authority	European Chemicals Agency (ECHA)
Framework	EU REACH
Product	Triacetin
Impact	Enables export to European markets
Validity	Subject to continued compliance

Strategic implications

This registration strengthens the company's regulatory compliance profile and enhances its access to international markets. It supports the broader corporate strategy of expanding global presence through targeted product registrations and regulatory approvals. No withdrawal, cancellation, or suspension of the license has been reported.

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