Alkem Laboratories , a prominent Indian pharmaceutical company, has successfully passed a Good Manufacturing Practice (GMP) inspection conducted by Armenia's Ministry of Health at its Sikkim facility. The inspection, which took place from November 21-22, 2025, concluded without any critical or major observations, underscoring the company's commitment to maintaining high-quality manufacturing standards.

Inspection Details

The two-day inspection at Alkem's Sikkim manufacturing facility was carried out by representatives from the Armenian Ministry of Health. The successful completion of this inspection without significant issues is a positive indicator of the company's adherence to international quality standards in pharmaceutical manufacturing.

Implications for Alkem Laboratories

The clearance of this GMP inspection may potentially bolster Alkem Laboratories' reputation in the global pharmaceutical market. It could possibly open doors for expanded market access in Armenia and other countries that recognize Armenian GMP certifications.

Financial Context

While this news primarily focuses on regulatory compliance, it's worth noting Alkem Laboratories' recent financial performance. As of March 2025, the company's consolidated balance sheet showed:

The company has demonstrated growth in total assets and equity, indicating a strong financial position. This financial stability complements its efforts in maintaining high-quality manufacturing practices, as evidenced by the successful GMP inspection.

Conclusion

Alkem Laboratories' successful clearance of the Armenian GMP inspection at its Sikkim facility reinforces its standing as a quality-focused pharmaceutical manufacturer. As the company continues to meet international regulatory standards, it positions itself well for potential market expansions and sustained growth in the global pharmaceutical industry.

Alkem Laboratories Limited , a leading Indian pharmaceutical company, has made a significant move in the gut health management sector by launching DSS, the original De Simone formulation probiotic blend, in India. This strategic entry into the prescription probiotic market, valued at approximately INR 2,071 crore, marks Alkem's commitment to addressing the growing demand for gut health solutions in the country.

Product Details

DSS, developed by Prof. Claudio De Simone, is a proprietary probiotic blend that combines eight carefully selected bacterial strains. These strains work synergistically to restore gut microbiota balance and manage various gastrointestinal conditions. The product's launch in India comes with four different strengths, catering to a wide range of patient needs:

Alkem is the first company in India to offer all four strengths of this probiotic, with exclusive marketing rights for the 225 billion CFU and 10 billion CFU variants.

Clinical Backing and Indications

The De Simone formulation is recognized as one of the world's most extensively researched probiotics, supported by over 80 clinical trials and 200 publications spanning two decades. It has received endorsements from leading American and European gastroenterology associations for managing gastrointestinal disorders.

DSS is indicated for various conditions, including:

• Irritable Bowel Syndrome (IBS)
• Ulcerative Colitis (UC)
• Pouchitis
• Hepatic Encephalopathy (HE)
• Non-Alcoholic Fatty Liver Disease (NAFLD)
• Cirrhosis
• Bacterial Vaginosis (BV)
• Antibiotic-Associated Diarrhea (AAD)

Additionally, it is recommended for supplementation during pregnancy and lactation.

Market Outlook

The Indian prescription probiotic market has shown significant growth, with a five-year Compound Annual Growth Rate (CAGR) of approximately 14%. This growth is driven by increasing consumer awareness and a rising prevalence of lifestyle-related digestive issues.

Dr. Vikas Gupta, Chief Executive Officer of Alkem, emphasized the strategic importance of this launch, stating, "The launch of DSS, a globally-trusted, high-potent, multi-strain probiotic, is a strategic addition to our comprehensive product portfolio in the gastrointestinal segment, and underscores our commitment to making innovative and evidence-based health solutions accessible to Indian patients."

As Alkem Laboratories continues to expand its portfolio in chronic therapies, including gastrointestinal health, the launch of DSS represents a significant step in addressing the growing need for effective gut health management solutions in India.