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Trimax Biosciences achieves EDQM Certificate of Suitability for Metformin Hydrochloride

Trimax Biosciences achieves EDQM Certificate of Suitability for Metformin Hydrochloride

Sigachi Industries announced that Trimax Biosciences, a Sigachi Group Company has successfully achieved the Certificate of Suitability (CEP) for Metformin Hydrochloride from European Directorate for the Quality of Medicines & Health Care (EDQM). This milestone paves the way for Trimax to export this crucial Active Pharmaceutical Ingredient (API) to Europe and other CEP-accepting markets, further strengthening Sigachi's presence in highly regulated pharmaceutical markets. Powered by Capital Market - Live News
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NSE issues retail algo trading rulebook, mandates strategy registration
NSE issues retail algo trading rulebook, mandates strategy registration

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time8 hours ago

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NSE issues retail algo trading rulebook, mandates strategy registration

With new norms taking effect for retail algorithmic (algo) trading from August 1, the National Stock Exchange (NSE) has released an operational rulebook aimed at fostering a safer and more transparent environment for traders using automated systems. The guidelines issued on Tuesday mandate the registration of all algo strategies, each of which will receive a unique identification (ID). Brokers will now be permitted to offer direct API access to their retail clients, though registration is mandatory. Further, it will be the brokers' responsibility to ensure that only eligible clients use the API or related facilities. For tech-savvy retail traders using their own algos, brokers will be required to disclose the PAN and unique client code of such clients. The application and registration of algo strategies must be done through a broker, with the algo ID allotted by the exchange. If there are more than 10 orders per second, the broker must register the algos developed by clients. Under the new framework, brokers will be held accountable for all orders routed through their terminals. The algo provider, in such cases, will act as an agent of the broker. The guidelines also prescribe several checks, including those related to price, quantity, order value, and position limits. This operational framework follows a circular issued by the Securities and Exchange Board of India (Sebi) in February, which sought to address grey areas in algo trading and ensure appropriate safeguards for retail participants. Market participants had called the guidelines necessary, citing the rise in retail participation and the growing share of algo trades. Algo trading is now widespread across both institutional and retail segments. Algo trading involves executing trades using pre-programmed strategies based on parameters such as price movements and volumes, allowing for automated buying or selling of securities. In FY25, the share of algo trading surged to 70 per cent in equity derivatives (notional turnover), according to the NSE Market Pulse report. Nilesh Sharma, executive director and president, SAMCO Securities, noted: 'These regulations bring much-needed clarity by clearly defining what qualifies as an algo strategy. Notably, low-frequency strategies—those generating fewer than 10 orders per second—are not classified as high-frequency algos. This distinction significantly reduces the compliance burden for retail users deploying simpler, rule-based systems, encouraging wider adoption of technology-driven trading in a responsible manner.' All algo providers will have to be empanelled with the exchange, except those that are in-house and provided by brokers. The turnaround time for empanelment has been set at T+30 working days, while strategy registration will be completed in T+10 working days. Registration for execution algos—where the logic is disclosed—will follow a fast-track process and be completed in T+7 working days. While registering for 'blackbox' or 'whitebox' algos, disclosures on the basic risk management system and an auditor certificate will be required. For blackbox algos—where logic is not disclosed—Sebi has mandated registration of the algo provider as a research analyst. Any change in the logic governing an algo will necessitate re-registration. 'Trading members providing API/algo provider facilities for routing client orders shall not be allowed to cross trades of their clients with each other. All orders must be offered to the market for matching,' the NSE guidelines added.

Dr Reddy's Lab receives EIR from USFDA for Middleburgh API facility
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Business Standard

time2 days ago

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Dr Reddy's Lab receives EIR from USFDA for Middleburgh API facility

Dr. Reddy's Laboratories announced that its Active Pharmaceutical Ingredient (API) manufacturing facility in Middleburgh, New York, has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA). In a regulatory filing, the company stated that the EIR was issued following a good manufacturing practice (GMP) inspection conducted by the USFDA. The inspection outcome has been classified as Voluntary Action Indicated (VAI), and the inspection is now officially closed under 21 CFR 20.64(d)(3). This follows Dr. Reddys earlier disclosure dated 17 May 2025, in which it informed that the USFDA had completed a GMP inspection of the Middleburgh facility. The inspection took place from 12 May to 16 May 2025 (US EST) and concluded with the issuance of a Form 483 containing two observations. The company confirmed that it will address the observations within the stipulated timeline. Hyderabad-based Dr. Reddys Laboratories is a global pharmaceutical company. It offers a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Dr. Reddys Laboratories reported a consolidated net profit of Rs 1,594 crore for the quarter ended March 2025 (Q4FY25), marking a 22% year-on-year increase from Rs 1,307 crore in the same period last year. Revenue from operations rose 20% year-on-year to Rs 8,506 crore, compared to Rs 7,083 crore in Q4FY24. The scrip shed 0.44% to Rs 1,254 on the BSE.

Aarti Drugs rises after Q1 PAT jumps 62% YoY to Rs 54 cr
Aarti Drugs rises after Q1 PAT jumps 62% YoY to Rs 54 cr

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time3 days ago

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Aarti Drugs rises after Q1 PAT jumps 62% YoY to Rs 54 cr

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