Shilpa Medicare Ltd Share Price – NSE  /  BSE

Pharmaceuticals, Small Cap

Shilpa Biologicals (SBPL), a wholly owned subsidiary of Shilpa Medicare has received registration approval for Adalimumab from Morocco, MoH. This is the first Biosimilar approval from any international market for high concentration Adalimumab developed by SBPL.

Shilpa Biologicals has developed high concentration adalimumab (100 mg/mL). Adalimumab contains Adalimumab as an active ingredient. Adalimumab is a fully human monoclonal IgG1 antibody produced recombinantly by Chinese Hamster Ovary (CHO)cells. Adalimumab consists of 1330 amino acid containing glycoprotein which has two copies of heavy- and two copies of light-chains in heterodimeric form with a molecular weight of 148 kDa (approx.). Adalimumab binds specifically to Tumor Necrosis Factor-alpha (TNF-á) and blocks its interaction with the p55 and p75 cell surface TNF receptor. Adalimumab is indicated for Rheumatoid Arthritis (RA) in adults.

The Adalimumab 40 mg/ 0.4 mL Solution for Injection is highly similar to the innovator (Humira) with respect to Quality, Safety and Efficacy.

SBPL has aggressively submitted its Adalimumab dossier in more than 15 emerging markets countries and is in the process of submitting the dossier to other countries as well.

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Shilpa Medicare's 100% subsidiary, Shilpa Pharma Lifesciences' Active Pharmaceutical Ingredient (API) manufacturing facility, Unit II, situated at Raichur in Karnataka state has undergone a GMP inspection by COFEPRIS-Mexico from November 6-10, 2023.

Following a successful inspection, the Unit has been issued GMP Certification from COFEPRIS-Mexico

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The GMP inspection was conducted in Raichur, Karnataka from 15th to 19th April 2024. Following a successful inspection, the Unit has been issued GMP Certification from ANVISA-Brazil.

The facility is involved in manufacturing various oncology and nononcology APIs. The company remains committed to maintain the GMP status and quality standards as per the expectations and standards of Global Regulatory Authorities.

Raichur-based Shilpa Medicare is a vertically integrated, manufacturer and distributor of quality drugs to global markets; specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance.

The company reported a consolidated net profit of Rs 24.50 crore in Q4 FY24 as against a net loss of Rs 8.04 crore posted in Q4 FY23. Revenue grew by 10.7% year on year to Rs 219.69 crore during the quarter.

The scrip fell 0.86% to Rs 652.45 on the BSE.

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Oxylanthanum Carbonate (OLC), a NCE molecule with potential treatment for hyperphosphatemia in chronic kidney disease patients which has several benefits for various patients in this chronic disease

SML partnered with Unicycive to provide end-to-end CDMO services right from development & supply of APIs to finished dosage form.

Unicycive is expected to file the New Drug Application for OLC by mid-2024 with potential approval by mid-2025.

Based on the outcome of the pivotal clinical studies, Unicycive has entered into long term manufacturing and supply agreement with SML and agreed to place a binding purchase order for supply of OLC tablets by June 30, 2025. Additionally, Unicycive has agreed to place orders for additional tablets to be delivered between December 31, 2025, and June 30, 2026.

Apart from the supply arrangement, SML is expected to receive $10 million as milestone income spanning over filing, approval and launch of the product. Additionally, in anticipation of increased product demand Unicycive will also fund the establishment of new manufacturing block at Shilpa’s site.

Raichur-based Shilpa Medicare is a vertically integrated, manufacturer and distributor of quality drugs to global markets; specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance.

The company reported a consolidated net profit of Rs 24.50 crore in Q4 FY24 as against a net loss of Rs 8.04 crore posted in Q4 FY23. Revenue grew by 10.7% year on year to Rs 219.69 crore during the quarter.

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