Shilpa Medicare

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

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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

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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

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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

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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

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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

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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)

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

• SHILPA MEDICARE LTD - FILES ROTIGOTINE TRANSDERMAL PATCH ANDA TO USFDA

Source text: ID:nNSE6v2cf3

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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

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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

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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)

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** Shares of Shilpa Medicare SHME.NS settle 5% higher at 913.7 rupees

** Pharma company's June-quarter consolidated net profit more than triples to 468.9 million rupees, revenue rises 10%

** SHME also approves bonus issue in ratio of 1:1

** More than 114,000 shares traded, nearly double their 30-day average

** Shares up 11% so far in 2025

(Reporting by Nishit Navin in Bengaluru)

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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

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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

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** Shares of Shilpa Medicare SHME.NS climb 4.5% to 932.6 rupees; set for best day in about 2 months

** Pharma co says U.S. FDA issues voluntary action indicated (VAI) classification for a Bengaluru facility

** VAI classification implies that the facility will not face any regulatory action

** YTD, stock up 14% so far

(Reporting by Manvi Pant in Bengaluru)

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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)

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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

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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

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

• SHILPA MEDICARE LTD - LAUNCHES NDA BORTEZOMIB FOR INJECTION3.5MG/1.4ML IN US

Source text: ID:nBSEbbvGZs

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** 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)

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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

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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

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March 7 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• SHILPA MEDICARE LTD - USFDA CONDUCTS INSPECTION AT SHILPA PHARMA UNIT-1

• SHILPA MEDICARE LTD - PHARMA RECEIVES ONE PROCEDURAL OBSERVATION FROM USFDA

Source text: ID:nBSE6XF7ph

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

• SHILPA MEDICARE LTD - RECEIVES CDSCO APPROVAL FOR NOR URSODEOXYCHOLIC ACID TABLETS

• SHILPA MEDICARE LTD - CDSCO RECOMMENDS MARKETING AUTHORIZATION FOR NAFLD TREATMENT

Source text: ID:nBSE1MjXx2

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Jan 23 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• SUBSIDIARY RECEIVED CERTIFICATE OF SUITABILITY FROM EDQM FOR API, TERIFLUNOMIDE

Source text: ID:nBSE24mLds

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Jan 10 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• GETS EUROPE APPROVAL FOR TADALAFIL ORODISPERIBLE FILMS

Source text: ID:nBSEc1X0WN

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Dec 20 (Reuters) - Shilpa Medicare Ltd SHME.NS:

• EUROPE GMP CERTIFICATE FOR UNIT VII, NACHARAM, HYDERABAD FROM EMA, AUSTRIA

Source text: ID:nBSE2TbwK6

Further company coverage: SHME.NS

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