The inspection was conducted from 24 September 2024 to 26 September 2024. On conclusion of the inspection the company has received the Good Manufacturing Practice (GMP) Certification. Unit VII of Shilpa Medicare houses an Analytical Services Division (QC) and a Bio-Analytical Department, both of which are approved by the USFDA. Notably, the Bio-Analytical Laboratory is already approved by EMA, Europe. This inspection was the first Europe inspection for the QC laboratory of Unit VII. This Laboratory is involved in testing drug substances, raw materials, packing materials and finished products. It is also engaged in other analytical activities like analytical method validations, method transfers and other miscellaneous analytical studies. The laboratory has been testing samples for final release into US, EU and other markets. 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's consolidated net profit soared to Rs 17.94 crore in Q2 FY25 as against Rs 1.61 crore posted in Q2 FY24. Revenue from operations rose 9.8% to Rs 343.80 crore in the quarter ended 30 September 2024. The scrip shed 0.03% to Rs 828.75 on the BSE. Powered by Capital Market - Live

Oncosol is 50:50 joint venture between Liqmeds Lifecare, a Zydus Group company, and Koana Healthcare, a Shilpa Medicare Group company. IMKELDI is an advanced liquid formulation of imatinib designed for dosing accuracy. It helps slow or prevent the growth of specific cancers, including chronic myeloid leukemia (CML), acute lymphoblastic leukemia, myelodysplastic syndrome (MDS), myeloproliferative disease (MPD), and gastrointestinal tumors (GIST). 'In 2024, an estimated 9,280 people will be diagnosed with CML, over 10,000 with MDS/MPD, and up to 6,000 with GIST in the U.S. Despite the proven clinical benefits of imatinib, patient adherence can be an issue, underscoring a critical unmet need for a more accessible, patient-friendly oral solution delivery system,' the company stated in exchange filing. 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's consolidated net profit soared to Rs 17.94 crore in Q2 FY25 as against Rs 1.61 crore posted in Q2 FY24. Revenue from operations rose 9.8% to Rs 343.80 crore in the quarter ended 30 September 2024. The scrip rose 0.42% to Rs 892.50 on the BSE.Powered by Capital Market - Live

Albumin is in high demand for various medical treatments, including restoring blood volume and replacing lost fluids during accidents, serious burn injuries, fatal erythroblastosis, hypoproteinemia, and surgeries. However, the supply of human serum albumin is limited due to the reliance on whole blood or donated human plasma. Shilpa's Recombinant Human Albumin 20% (rHA), derived from yeast, offers a highly purified, structurally and functionally equivalent alternative to human serum albumin. The company has successfully completed its Phase I clinical trials on 7 August 2024. With today's announcement, the company confirms that the SEC has accepted the trial results and approved the progression to Phase III trials for rHA 20%. The Phase III trials will be conducted according to the protocol approved by the SEC. Shilpa is the first company in India to receive the approval for conducting Phase III clinical trials. This approval clears regulatory strategy for India and various emerging markets that accept Indian studies and is an important step towards providing a reliable and safe alternative to human serum albumin, addressing the global demand and supply challenges. 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's consolidated net profit soared to Rs 17.94 crore in Q2 FY25 as against Rs 1.61 crore posted in Q2 FY24. Revenue from operations rose 9.8% to Rs 343.80 crore in the quarter ended 30 September 2024. The scrip shed 0.66% to Rs 889.25 on the BSE. Powered by Capital Market - Live

The key equity indices traded with substantial gains in early afternoon trade. The Nifty traded above the 23,700 level. Auto shares extended gains for the third consecutive trading session. At 12:30 IST, the barometer index, the S&P BSE Sensex, climbed 1,007.70 points or 1.30% to 78,346.71. The Nifty 50 index soared 293.40 points or 1.25% to 23,747.20. In the broader market, the S&P BSE Mid-Cap index rallied 1.72% and the S&P BSE Small-Cap index jumped 1.80%. The market breadth was strong. On the BSE, 2,862 shares rose and 942 shares fell. A total of 120 shares were unchanged. Derivatives: The NSE's India VIX, a gauge of the market's expectation of volatility over the near term, tumbled 5.35% to 14.36. The Nifty 28 November 2024 futures were trading at 23,816.35, at a premium of 69.15 points as compared with the spot at 23,747.20. The Nifty option chain for the 28 November 2024 expiry showed maximum Call OI of 42.01 lakh contracts at the 24,000 strike price. Maximum Put OI of 53.8 lakh contracts were seen at 23,000 strike price. Buzzing Index: The Nifty Auto index added 2.33% to 23,581.15. The index rallied 3.58% in the three consecutive trading sessions. Mahindra & Mahindra (up 3.63%), Apollo Tyres (up 3.29%), Exide Industries (up 3.16%), Bharat Forge (up 3.05%) and Bosch (up 2.9%), Tata Motors (up 2.73%), Eicher Motors (up 2.55%), Hero MotoCorp (up 2.42%), Samvardhana Motherson International (up 2.17%) and TVS Motor Company (up 2.01%) advanced. Stocks in Spotlight : Shilpa Medicare rallied 3.77% after the company's 100% subsidiary, Shilpa Pharma Lifesciences received certificate of suitability (CEP) from EDQM (European Directorate for the Quality of Medicines & Healthcare) for API, Octreotide. Meanwhile, Shilpa Pharma Lifesciences also received certificate of suitability (CEP) from EDQM (European Directorate for the Quality of Medicines & Healthcare) for API, Nifedipine. V-Mart Retail rose 0.85%. The company informed that a fire accident occurred at one of its stores located in Ahmedabad, Gujarat, on Monday, 18 November 2024. Easy Trip Planners added 2.27% after the company's board fixed Thursday, 8 November 2024 as the record date for the proposed bonus issue of equity shares. On 14 October 2024, the company's board had approved the issuance of one bonus equity share for every one fully paid-up equity share held by shareholders (1:1) as on record date.Powered by Capital Market - Live

Octreotide, a synthetic peptide manufactured by Shilpa Pharma Lifesciences through solid-phase synthesis, is used in the treatment of conditions such as acromegaly, severe diarrhea/flushing episodes associated with metastatic carcinoid tumors, and profuse watery diarrhea associated with Vasoactive Intestinal Peptide (VIP)-secreting tumors. This approval marked Octreotide as the second peptide molecule in Shilpa's peptide portfolio. The CEP highlighted the company's expertise and commitment to quality-oriented development and commercial production, meeting global quality standards. Meanwhile, Shilpa Pharma Lifesciences also received certificate of suitability (CEP) from EDQM (European Directorate for the Quality of Medicines specializing in the oncology therapeutic segment and introducing novel drugs focusing on patient convenience and compliance. The drug maker's consolidated net profit soared 1042.68% to Rs 17.94 crore on a 9.85% rise in revenue from operations to Rs 343.80 crore in Q2 FY25 over Q2 FY24. Powered by Capital Market - Live

Net profit of Shilpa Medicare rose 1014.29% to Rs 17.94 crore in the quarter ended September 2024 as against Rs 1.61 crore during the previous quarter ended September 2023. Sales rose 9.85% to Rs 343.80 crore in the quarter ended September 2024 as against Rs 312.98 crore during the previous quarter ended September 2023. ParticularsQuarter EndedSep. 2024Sep. 2023% Var. Sales343.80312.98 10 OPM %24.9018.66 - PBDT65.0536.96 76 PBT36.779.17 301 NP17.941.61 1014 Powered by Capital Market - Live

Unicycive Therapeutics, Inc. (NASDAQ: UNCY) has announced that the U.S. Food and Drug Administration (USFDA) has accepted the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) and has set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025. If approved, OLC has the potential to meaningfully improve the treatment burden for hyperphosphatemia patients with chronic kidney disease (CKD) on dialysis. CKD patients on dialysis with hyperphosphatemia are often saddled with an onerous treatment regimen that includes having to take as many as 12 pills per day. OLC is likely to result in better patient adherence over currently available treatment options as it requires a lower pill burden in terms of the number and size of pills per dose, and the pills are swallowed instead of chewed for added convenience. Unicycive has entered into a long term manufacturing contract with Shilpa Medicare for the supply of the product at commercial scale once approved by the USFDA. With Unicycive's NDA now under review, it is expected to commercialize and launch OLC in the US market in the second half of calendar year 2025.Powered by Capital Market - Live

Shilpa Medicare will hold a meeting of the Board of Directors of the Company on 13 November 2024Powered by Capital Market - Live

The domestic equity indices traded with major losses in mid-afternoon trade. The Nifty hovered below the 24,200 level. Bank shares extended losses for the two trading session. Trading could be volatile due to monthly F&O series expiry today. At 14:30 IST, the barometer index, the S&P BSE Sensex, tumbled 596.06 points or 0.75% to 79,339.11. The Nifty 50 index declined 155.05 points or 0.64% to 24,185.45. In the broader market, the S&P BSE Mid-Cap index fell 0.64% and the S&P BSE Small-Cap index shed 0.75%. The market breadth was positive. On the BSE, 2,457 shares rose and 1,380 shares fell. A total of 121 shares were unchanged. Both, BSE and NSE will conduct the Muhurat trading session on Friday, 1 November, from 6:00 pm to 7:00 pm. While markets remain closed during the day, this evening session allows investors to make token investments, following a long-standing custom of trading during Diwali. Buzzing Index: The Nifty Bank index fell 0.84% to 51,370.25. The index declined 0.34% in the two trading sessions. DFC First Bank (down 3.11%), Punjab National Bank (down 2.69%), Bank of Baroda (down 1.1%), ICICI Bank (down 1.02%), Canara Bank (down 0.97%), Axis Bank (down 0.96%), State Bank of India (down 0.89%), Federal Bank (down 0.83%), IndusInd Bank (down 0.61%) and HDFC Bank (down 0.54%) declined. Numbers to Track: The yield on India's 10-year benchmark federal paper advanced 1.85% to 6.953 as compared with previous close 6.945. In the foreign exchange market, the rupee edged lower against the dollar. The partially convertible rupee was hovering at 84.0950, compared with its close of 84.0850 during the previous trading session. MCX Gold futures for 5 December 2024 settlement shed 0.36% to Rs 79,445. The US Dollar index (DXY), which tracks the greenback's value against a basket of currencies, was down 0.03% to 103.96. The United States 10-year bond yield declined 0.89% to 4.237. In the commodities market, Brent crude for November 2024 settlement added 12 cents or 0.17% to $72.67 a barrel. Stocks in spotlight: Shilpa Medicare fell 0.95%. The company announced that the US FDA had issued four observations to its Bengaluru-based facility post the conclusion of an inspection. The company informed the company's Unit- VI, Dabaspet, Bengaluru, India, was inspected by USFDA on 24, 25 and 28, 29, 30 October 2024. The inspection was the onsite GMP inspection of this site. Automotive Axles slipped 2.20% after the company's standalone net profit declined 20.20% to Rs 35.97 crore on 15.35% decrease in revenue from operations to Rs 494.68 crore in Q2 September 2024 over Q2 September 2023. Powered by Capital Market - Live

In a regulatory filing made during market hours today, the company informed the company's Unit- VI, Dabaspet, Bengaluru, India, was inspected by USFDA on 24, 25 and 28, 29, 30 October 2024. The inspection was the onsite GMP inspection of this site. The inspection concluded with the issuance of Form 483 with four observations. All observations are procedural in nature. 'The company shall respond to the observations within the time frame,' Shilpa Medicare said. This unit of Shilpa Medicare is engaged in the manufacturing, testing and release of oral mouth dissolving films and transdermal systems. The site has already been approved by MHRA-UK and TGA Australia and has US FDA approval for supplying nutraceutical oral film products into US and other markets. 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 consolidated net profit of Rs 14.06 crore in Q1 FY25, steeply higher than Rs 1.18 crore posted in Q1 FY24. Revenue from operations grew by 12.4% YoY to Rs 292.51 crore in the quarter ended 30 June 2024. Powered by Capital Market - Live