Akums Drugs Receives European GMP Certificates for Haridwar Manufacturing Facilities
Akums Drugs and Pharmaceuticals Limited received European GMP certificates from the Bulgarian Drug Agency for its Plant 1 and Plant 2 facilities at Haridwar. Plant 1 obtained a renewal while Plant 2 secured first-time certification. The three-year certifications enable access to EU regulated markets, with Plant 1 authorized for tablets and capsules, and Plant 2 for oral liquid formulations and European CDMO contract servicing.
*this image is generated using AI for illustrative purposes only.
Akums drugs & pharma has secured European GMP certificates for its two manufacturing facilities located at Haridwar, Uttarakhand, marking a significant regulatory milestone for the pharmaceutical company. The certification was granted by the Bulgarian Drug Agency (BDA) and represents both a renewal and a fresh approval for the company's manufacturing capabilities.
Certification Details
The European GMP certificates cover two distinct facilities with different approval statuses:
| Facility: | Certification Status | Products Authorized |
|---|---|---|
| Plant 1 | Renewal of existing EU-GMP approval | Tablets, hard gelatine capsules, sachet dosage forms |
| Plant 2 | First-time EU-GMP certification | Oral liquid formulations |
Both certifications are valid for a period of three years, extending until October 2028, providing the company with a stable regulatory framework for European market operations.
Market Access and Business Impact
The European GMP accreditations will enable Akums Drugs and Pharmaceuticals Limited to expand its market reach significantly. The certifications provide access to:
- EU regulated markets
- Several other international markets that follow EU-GMP regulations
- New business opportunities from European Union countries
The company has already positioned itself to leverage these approvals, with Plant 2 designated to service the European CDMO contract that was signed in December 2024.
Manufacturing Capabilities
With the new certifications, each facility is authorized for specific product categories:
Plant 1 Authorization:
- Tablets manufacturing and supply
- Hard gelatine capsules production
- Sachet dosage forms
Plant 2 Authorization:
- Oral liquid formulations manufacturing
- Supply capabilities for EU countries
- Service delivery for European CDMO operations
Regulatory Compliance
The company disclosed this development under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, demonstrating its commitment to transparency and regulatory compliance. The Bulgarian Drug Agency serves as the regulatory authority for these European GMP certifications, ensuring adherence to stringent European pharmaceutical manufacturing standards.
These certifications represent a strategic advancement for Akums Drugs and Pharmaceuticals Limited, positioning the company to capitalize on European market opportunities while maintaining compliance with international pharmaceutical manufacturing regulations.
Historical Stock Returns for Akums Drugs & Pharma
| 1 Day | 5 Days | 1 Month | 6 Months | 1 Year | 5 Years |
|---|---|---|---|---|---|
| +2.38% | -4.00% | -0.91% | +49.10% | +72.43% | -3.38% |
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