Shilpa Medicare in South Africa

Shilpa Medicare’s Strategic Expansion and Regulatory Milestones

Hyderabad, India – August 1, 2025

Shilpa Medicare Limited, a prominent pharmaceutical and biotechnology company, has recently achieved significant regulatory approvals and strategic partnerships, underscoring its commitment to global healthcare advancement.

Partnership with Orion Corporation for Recombinant Human Albumin

In May 2025, Shilpa Biocare Private Limited, a wholly-owned subsidiary of Shilpa Medicare, entered into a strategic partnership with Finland-based Orion Corporation. This collaboration focuses on the commercialization of Shilpa’s Recombinant Human Albumin across the European market. Orion will exclusively handle the distribution, marketing, and sales of this product, with Shilpa set to receive development and regulatory milestone payments. This partnership highlights Shilpa’s dedication to providing high-quality, affordable biologics globally. (medicaldialogues.in)

Regulatory Approvals and Market Authorizations

Shilpa Medicare has secured several key regulatory approvals:

• Germany: In January 2024, the company received marketing authorization for Amifampridine Tablets, 10 mg, under the National Procedure. This drug is primarily used in the treatment of rare muscle diseases, including Lambert-Eaton myasthenic syndrome (LEMS). (medicaldialogues.in)

• United Kingdom: In September 2023, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) approved Betahistine Dihydrochloride Orodispersible Films, a treatment for hearing loss associated with Meniere’s syndrome. This approval marked Shilpa Medicare as the first company to receive authorization for the 24 mg strength in film formulation in the UK. (cnbctv18.com)

• United States: In September 2024, Shilpa Medicare submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Oxylanthanum Carbonate, a treatment for hyperphosphatemia in chronic kidney disease patients. This submission, made via Unicycive Therapeutics, signifies Shilpa’s expanding footprint in the US market. (cnbctv18.com)

Clinical Trial Successes

The company has also reported positive outcomes in its clinical trials:

• Phase 3 Trials for Non-Alcoholic Fatty Liver Disease (NAFLD): In August 2024, Shilpa Medicare announced the successful completion of Phase 3 clinical studies for its novel product, SMLNUD07 – Nor Ursodeoxycholic Acid (NorUDCA) tablets. This treatment addresses the needs of the approximately 188 million individuals in India affected by NAFLD. (cnbctv18.com)

• Phase 1 Trial for Recombinant Human Albumin: In August 2024, Shilpa Medicare became the first Indian company to complete a Phase 1 clinical trial for its Recombinant Human Albumin (rHA) 20%. The trial demonstrated that rHA is a viable alternative to plasma-derived human serum albumin, potentially alleviating global supply concerns. (prnewswire.com)

Market Performance

These developments have positively impacted Shilpa Medicare’s stock performance. In August 2024, the company’s shares surged by over 11%, reaching a new 52-week high of ₹778.2 per share, following the announcement of the successful Phase 3 trial outcomes for NorUDCA. (cnbctv18.com)

Shilpa Medicare’s strategic initiatives and regulatory achievements reflect its ongoing commitment to innovation and global healthcare improvement.

Shilpa Medicare’s Recent Regulatory Milestones:

• Shilpa Medicare arm partners with Orion Corporation for Recombinant Human Albumin for European Market
• Shilpa Medicare share price hits 10-month high after UK drug regulator approves new launch – CNBC TV18
• Shilpa Medicare submits new drug application to USFDA for kidney disease treatment, stock hits all-time high – CNBC TV18