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Latest news about Shilpa Medicare

Shilpa Medicare's Pharma Unit Clears ANVISA Inspection with Flying Colors 1 day ago Yesterday

Shilpa Medicare Limited's Shilpa Pharma Lifesciences Unit-1 successfully completed a Good Manufacturing Practice (GMP) inspection by ANVISA, Brazil's Health Regulatory Agency, with no critical or major observations. This achievement validates the company's quality management systems and manufacturing processes, potentially enhancing its access to the Brazilian pharmaceutical market and demonstrating compliance with international regulatory standards.

Shilpa Medicare's Pharma Unit Clears ANVISA Inspection with Minor Observations 4 days ago

Shilpa Medicare's Amalgamation with InM Technologies Receives NCLT Approval 10 days ago

Shilpa Medicare Advances Drug Pipeline: NORUDCA Approval Expected in FY26 May 27, 2025

Shilpa Medicare Outlines Strategic Plans for Product Launches and Business Growth May 27, 2025

More news about Shilpa Medicare

26May 25

Shilpa Medicare Q4 Results: EBITDA Up, Net Profit Down; Announces ₹1 Per Share Dividend

Shilpa Medicare's Q4 results show revenue growth of 13.01% YoY to ₹3.30 billion and EBITDA increase of 9.71% to ₹768.00 million. However, net profit declined 40.82% YoY to ₹145.00 million. The company announced a dividend of ₹1 per equity share.

23May 25

Shilpa Medicare Unit Secures European Distribution Deal with Orion Corporation

Shilpa Medicare's unit has entered into a strategic partnership with Orion Corporation, granting the latter exclusive rights for distribution, marketing, and sales of Shilpa's recombinant human albumin in Europe. This collaboration aims to expand Shilpa Medicare's presence in the European pharmaceutical market, leveraging Orion's established network. The deal focuses on recombinant human albumin, a vital protein used in various medical applications, showcasing Shilpa's biotechnology expertise. While financial terms were not disclosed, this agreement could potentially boost Shilpa Medicare's revenue from the European market.

15May 25

Shilpa Medicare's Subsidiary Receives USFDA Approval with VAI Classification

Shilpa Pharma Lifesciences Ltd, a subsidiary of Shilpa Medicare Limited, has received an Establishment Inspection Report (EIR) from the USFDA for its Unit-1 facility. The inspection, conducted from March 3 to March 7, 2025, resulted in a Voluntary Action Indicated (VAI) classification. This favorable outcome indicates that the facility largely meets regulatory standards, with only minor issues that can be addressed voluntarily. The VAI classification is expected to positively impact Shilpa Medicare's operations and potential expansion in the U.S. market.

14May 25

Shilpa Medicare's Subsidiary Receives USFDA Approval with VAI Classification

Shilpa Pharma Lifesciences Ltd, a subsidiary of Shilpa Medicare Limited, has received an Establishment Inspection Report (EIR) from the USFDA following an inspection of its Unit-1 facility from March 3 to March 7, 2025. The USFDA classified the site as Voluntary Action Indicated (VAI), indicating minor issues that don't require official FDA action. This outcome demonstrates the company's alignment with FDA standards and positions it for potential growth in the U.S. market.

21Apr 25

Shilpa Medicare Reaches $3.4 Million Settlement with Celltrion

Shilpa Medicare Limited has reached a settlement agreement with Celltrion, a South Korean biopharmaceutical company, for $3.40 million. The settlement will be paid in installments until July 2025. This resolution is expected to provide clarity and stability for Shilpa Medicare's future operations. The specific reasons for the dispute were not disclosed.

17Apr 25

Shilpa Medicare Settles Dispute with Celltrion for $3.4 Million

Shilpa Medicare Limited has reached a settlement agreement with Celltrion, Inc., ending a legal dispute over a 2019 supply and distribution agreement. The settlement, disclosed on April 17, 2025, requires Shilpa Medicare to pay $3.40 million to Celltrion in installments until July 2025. This agreement follows an arbitration process by the London Court of International Arbitration and reduces the initially awarded amount. Shilpa Medicare states that the settlement payment is not expected to impact its future operations.

09Apr 25

Shilpa Medicare Secures USFDA Approval for Varenicline Tablets, Eyeing $203M US Market

Shilpa Medicare Limited has received USFDA approval for Varenicline tablets in 0.5 mg and 1 mg strengths on April 9, 2025. This generic version will compete with Chantix Tablets in the US market, estimated at $203 million. Varenicline is a prescription medication for smoking cessation. Shilpa Medicare, based in Raichur, Karnataka, is an integrated pharmaceutical company with diverse capabilities in oncology and non-oncology APIs, peptides, polymers, and various formulations. The company operates four R&D units and seven manufacturing facilities.

03Apr 25

Shilpa Medicare Launches BORUZU™: A Ready-to-Use Bortezomib Injection in US Market

Shilpa Medicare Limited has introduced BORUZU™ (Bortezomib for injection 3.5mg/1.4mL), its second NDA product, in the United States. BORUZU™ is a ready-to-use oncology drug for treating multiple myeloma and mantle cell lymphoma, referencing the branded drug Velcade®. The product offers versatile administration options and has received a permanent J-code from CMS. Amneal Pharmaceuticals will handle manufacturing and commercialization in the US market.

18Mar 25

Shilpa Medicare's Biologicals Unit Partners with mAbTree for Novel Cancer Therapy

Shilpa Biologicals Private Limited, a subsidiary of Shilpa Medicare Limited, has entered into a binding term sheet with mAbTree Biologics AG for co-development, manufacture, and commercialization of a New Biological Entity. The collaboration focuses on developing a novel checkpoint inhibitor for immuno-oncological applications, aiming to create a fully human monoclonal antibody that targets a new immune checkpoint protein. This therapy shows promise for various cancers, including lung cancer and head and neck squamous cell carcinoma. Shilpa Biologicals will support development phases and provide GMP manufacturing at its Dharwad facility.

17Mar 25

Shilpa Medicare's Subsidiary Inks Strategic Partnership with mAbTree Biologics for Novel Cancer Treatment

Shilpa Biologicals, a subsidiary of Shilpa Medicare, has entered a strategic partnership with mAbTree Biologics AG to co-develop, manufacture, and commercialize a New Biological Entity for cancer treatment. The collaboration focuses on developing a fully human monoclonal antibody targeting a novel immune checkpoint protein, aiming to enhance T cell activation and immune responses against tumors. Shilpa will provide manufacturing support and access to Indian and global markets. The therapy shows potential for various cancers, including lung cancer and hematologic malignancies.

17Mar 25

Shilpa Medicare's Subsidiary Aces USFDA Inspection with Zero Observations

Shilpa Medicare Limited's subsidiary, Shilpa Pharma Lifesciences Limited, has successfully passed a USFDA inspection at its Unit-2 in Raichur with zero observations. The inspection, conducted from March 10-14, 2025, concluded flawlessly, potentially strengthening the company's position in the U.S. pharmaceutical market and enhancing investor confidence.

10Mar 25

Shilpa Medicare's Unit-1 Receives Single Observation in FDA Inspection

Shilpa Medicare Limited's Unit-1 of Shilpa Pharma Lifesciences underwent an FDA inspection, resulting in one procedural observation in Form 483. This outcome is generally viewed positively, indicating no significant issues with product quality, safety, or efficacy. The company is expected to address the observation promptly to maintain good standing with the FDA.

07Mar 25

Shilpa Medicare's Unit-1 Receives One Observation in USFDA Inspection

Shilpa Medicare Limited's subsidiary, Shilpa Pharma Lifesciences Limited, underwent a USFDA inspection at its Unit-1 facility in Raichur, Karnataka from March 3-7, 2025. The inspection resulted in one procedural observation in Form 483. The company has committed to addressing this observation comprehensively within the stipulated time, demonstrating its commitment to regulatory compliance.