Shilpa Medicare

Shilpa Medicare received final approval from the Subject Expert Committee of India's central drug regulator for the grant of marketing authorization for OERIS, a 100 mg/mL extended-release ondansetron injection. The formulation was designed to provide antiemetic protection for up to 120 hours after a single administration for patients receiving moderately to highly emetogenic chemotherapy. The approval followed a multicentre, randomized, double-blind Phase III trial, while commercial launch in India remained subject to receipt of final marketing authorization from the CDSCO; the product was patent protected in India until 2039. Shilpa reported consolidated operating revenue of ₹1,539 crore in FY26, with APIs contributing 49%, formulations 40% and biologics 10%.

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** Shares of India's Shilpa Medicare SHME.NS rise 2.2% to 960.75 rupees

** Drugmaker says it received final approval from Subject Expert Committee (SEC) under India's Central Drugs Standard Control Organization (CDSCO) for marketing authorization of OERIS, an extended-release ondansetron injection

** Adds OERIS is designed to provide antiemetic protection for up to 120 hours following a single administration

** Co says the product will be launched in India and has patent protection in the country until 2039

** Stock up nearly three-fold YTD

(Reporting by Payel Das in Bengaluru)

(([email protected]))

Shilpa Medicare’s wholly owned subsidiary FTF Pharma entered the corporate insolvency resolution process after the NCLT’s Ahmedabad bench admitted a Section 9 petition by Immacule Lifesciences over a claimed operational debt of ₹2.18 crore. The tribunal imposed a moratorium and appointed Sunil Kumar Kedia as interim resolution professional. Shilpa Medicare said no violation by the listed company had been alleged or determined, and that any impact on its own financial or operational activities was not presently ascertainable or quantifiable. The group reported FY26 consolidated revenue of ₹1,539 crore, debt of ₹658 crore and capital expenditure of ₹361 crore.

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Aug 18 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• SHILPA MEDICARE - INITIATES VOLUNTARY RECALL OF 27,923 PEMETREXED INJECTION VIALS IN US ON JULY 29, 2026

• SHILPA MEDICARE - RECALL COVERS 4 BATCHES DUE TO ATYPICAL DISCOLORATION OF DRUG PRODUCT

• SHILPA MEDICARE - US FDA CLASSIFIES RECALL AS CLASS II (HOSPITAL LEVEL)

• SHILPA MEDICARE - RECALL DOES NOT AFFECT OTHER PRODUCTS OR SUPPLY

• SHILPA MEDICARE - NO ADVERSE EVENT REPORTED FOR AFFECTED BATCHES

• SHILPA MEDICARE - COMPANY DOES NOT FORESEE MATERIAL IMPACT OF RECALL ON FINANCIAL POSITION OR OPERATIONS

Source text: ID:nBSE2zBQ4q

Further company coverage: SHME.NS

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Aug 5 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• JUNE-QUARTER CONSOL NET PAT 1.01 BILLION RUPEES

• JUNE-QUARTER CONSOL NET SALES 3.9 BILLION RUPEES

Source text: ID:nnAZN4TBXOZ

Further company coverage: SHME.NS

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Shilpa Medicare's subsidiary Shilpa Biologicals has signed a co-development and supply agreement with Finnish pharmaceutical company Orion Corporation for a Nivolumab biosimilar to be sold across Europe. The deal combines Shilpa's end-to-end biologics development and manufacturing capabilities at its Dharwad facility with Orion's regulatory and commercial expertise in Europe. Orion will hold exclusive marketing rights and act as the Marketing Authorisation holder, while Shilpa will lead product development and serve as the exclusive long-term supplier. The partnership targets the immuno-oncology blockbuster Nivolumab, which recorded approximately USD 4.1 billion in European sales in 2025, as the originator approaches loss of exclusivity. Shilpa will receive development and regulatory milestone payments in addition to supply revenue over the life of the agreement. The financial terms of the deal were not disclosed.

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June 30 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• SHILPA MEDICARE - UNIT ENTERS CO-DEVELOPMENT AND SUPPLY AGREEMENT WITH ORION CORPORATION

Source text: ID:nBSE7SLDn5

Further company coverage: SHME.NS

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Shilpa Biologicals, a material subsidiary of Shilpa Medicare, commissioned a state-of-the-art antibody–drug conjugate (ADC) GMP manufacturing facility at Dharwad, the company announced on 24 June 2026. The facility is fully operational and has entered GMP qualification protocols, targeting compliance with US FDA, EMA and other global health authority standards. With this commissioning, Shilpa becomes one of the very few companies in India offering fully integrated ADC drug substance development and manufacturing – from payload synthesis and linker production to monoclonal antibody production, conjugation and purification. The company aims to position itself as a cost-competitive CDMO partner for worldwide biotech and pharmaceutical companies in the oncology space. Managing Director Vishnukant Bhutada described the facility as a decisive step in building a globally relevant CDMO platform for advanced ADC manufacturing.

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June 24 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• SHILPA MEDICARE - UNIT ENTERS SETTLEMENT AGREEMENT WITH SARTORIUS STEDIM INDIA FOR 90 MILLION RUPEES ON JUNE 23, 2026

Source text: ID:nNSE1BG81F

Further company coverage: SHME.NS

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June 3 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• SHILPA MEDICARE - UNIT INTENDS TO MAKE A STRATEGIC EQUITY PARTNERSHIP OF 30.4% IN GATE2BRAIN

• SHILPA MEDICARE LTD- COST OF ACQUISITION IS 7 MILLION EUROS

Source text: [ID:]

Further company coverage: SHME.NS

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May 22 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• SHILPA MEDICARE MARCH-QUARTER CONSOL NET PAT 1.08 BILLION RUPEES

• SHILPA MEDICARE MARCH-QUARTER CONSOL REVENUE FROM OPERATIONS 4.37 BILLION RUPEES

Source text: ID:nNSE5snXBr

Further company coverage: SHME.NS

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March 5 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• NCLT APPROVES AMALGAMATION OF SHILPA THERAPEUTICS WITH SHILPA MEDICARE

Source text: ID:nBSEw91wt

Further company coverage: SHME.NS

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Feb 24 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• SHILPA MEDICARE LTD - BIOLOGICALS AND STEINCARES TO COMMERCIALIZE BIOSIMILAR IN LATIN AMERICA

• SHILPA MEDICARE LTD - BIOLOGICALS TO DEVELOP AND MANUFACTURE BIOSIMILAR IN INDIA

Source text: ID:nBSE1MMxp4

Further company coverage: SHME.NS

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Feb 13 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• ENTERS AGREEMENT WITH NXI THERAPEUTICS FOR NEW CHEMICAL ENTITY

Source text: ID:nBSEDlkPS

Further company coverage: SHME.NS

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** Shares of India's Shilpa Medicare SHME.NS up 7.2% to 339 rupees

** Co's third-qtr consol core profit rises 40% y/y, total rev up 28%

** Trading vols over 1.7 mln shares vs 30-day avg of ~502k shares

** YTD stock up over 5%

(Reporting by Hritam Mukherjee in Bengaluru)

(([email protected];))

Feb 6 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• SHILPA MEDICARE DEC-QUARTER CONSOL NET PAT 445.8 MILLION RUPEES

• SHILPA MEDICARE DEC-QUARTER CONSOL REVENUE FROM OPERATIONS 4.1 BILLION RUPEES

Source text: ID:nBSE2TZj36

Further company coverage: SHME.NS

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Jan 28 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• CO AND MABTREE BIOLOGICS RECEIVE FDA ORPHAN DRUG DESIGNATION

Source text: ID:nNSEsVkvf

Further company coverage: SHME.NS

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Dec 30 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• SHILPA MEDICARE LTD - RECEIVES INJUNCTION FROM DELHI HIGH COURT

• SHILPA MEDICARE LTD - RESTRAINED FROM MANUFACTURING AND EXPORTING RUXOLITINIB

Source text: ID:nNSE7Ggr0N

Further company coverage: SHME.NS

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** Shares of Shilpa Medicare SHME.NS rise 3.2% to 845 rupees, their biggest intraday-pct gain in over 5 weeks

** Drug maker gets initial clearance from European drug regulator recommending final approval to sell Rivaroxaban Orodispersible Films, used to treat blood clots, heart attack, stroke in adults

** Europe market for oral Rivaroxaban formulations seen at about $2.5 billion - SHME

** Over 135,000 shares traded, over twice the 30-day avg

** Stock up 3.6% YTD

(Reporting by Aleef Jahan)

(([email protected]))

Aug 13 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• JUNE-QUARTER CONSOL NET PAT 468.9 MILLION RUPEES

• JUNE-QUARTER CONSOL INCOME FROM OPERATIONS 2.64 BILLION RUPEES

• RE-APPOINTMENT OF CHAIRMAN OM PRAKASH INANI

• ISSUE OF BONUS EQUITY SHARES IN RATIO OF 1:1

Source text: [ID:]

Further company coverage: SHME.NS

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Aug 8 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• SHILPA MEDICARE LTD - TO CONSIDER ISSUE OF BONUS SHARES

Source text: ID:nBSE71Gd5H

Further company coverage: SHME.NS

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July 24 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• SHILPA MEDICARE LTD - UNIT TO INVESTS $2 MILLION IN ALVEOLUS BIO

Source text: ID:nBSE946Hpt

Further company coverage: SHME.NS

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July 16 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• SHILPA MEDICARE LTD - UNIT VI RECEIVES EIR FROM USFDA

• SHILPA MEDICARE LTD - RECEIVED EIR WITH VAI CLASSIFICATION FROM USFDA

Source text: ID:nBSE7khHSG

Further company coverage: SHME.NS

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** Shilpa Medicare SHME.NS up 4.4% to 658.4 rupees

** Co's biologics arm Shilpa Biologics' site in Karnataka gets European Good Manufacturing Practice (GMP) certification for manufacturing of test batches

** Stock set to snap five straight sessions of losses

** SHME trims YTD losses to ~19%

(Reporting by Anuran Sadhu in Bengaluru)

(([email protected]; +91 8697274436;))

April 17 (Reuters) - Celltrion Inc 068270.KS:

• ENTERING INTO A SETTLEMENT WITH CELLTRION

• SETTLEMENT FOR US$3.4 MILLION

• CO WILL PAY CELLTRION $ 3.4 MILLION, PAYABLE IN A STAGGERED MANNER TILL JULY 2025

Source text: ID:nBSE9MZBLd

Further company coverage: 068270.KS

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April 9 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• US APPROVAL FOR VARENICLINE TABLETS

• RECEIVED APPROVAL FROM USFDA FOR VARENICLINE TABLETS, 0.5 AND 1 MG

Source text: ID:nBSE1NbXmT

Further company coverage: SHME.NS

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** Shares of Shilpa Medicare SHME.NS rise 4.7% to 678.5 rupees

** Co's partner, Amneal Pharma, launched IV administered-version of its cancer drug Boruzu

** Trading volume of ~500,000 shares is 1.4x its 30-day avg

** Stock has shed 20% so far this year

(Reporting by Ashna Teresa Britto in Bengaluru)

(([email protected] ; ( +91 8078332441))

** Shares of Shilpa Medicare SHME.NS rise 2.4% at 645 rupees

** SHME on Monday says its unit enters into deal with Switzerland-based mAbTree Biologics for development, manufacture, marketing and sale of a new biological entity

** Stock set to gain for a second session straight

** SHME shares down ~23% so far this year; pharma index .NIPHARM down ~11%

(Reporting by Yagnoseni Das in Bengaluru)

(([email protected];))

March 17 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• SHILPA BIOLOGICALS ENTERED INTO A BINDING TERM SHEET WITH MABTREE BIOLOGICS AG

• TERM SHEET FOR DEVELOPMENT, MANUFACTURE, MARKETING, SALE OF NEW BIOLOGICAL ENTITY

Source text: ID:nBSEbZ3Nz0

Further company coverage: SHME.NS

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March 14 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• USFDA INSPECTION AT SHILPA PHARMA UNIT-2 CLOSED WITH ZERO OBSERVATIONS

Source text: ID:nBSE3MDjcb

Further company coverage: SHME.NS

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