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Pharma major Venus Remedies Limited on Saturday said it has received marketing authorisation from the Saudi Food and Drug Authority (SFDA) for speciality oncology therapy -- Plerixafor. Plerixafor is a hematopoietic stem cell mobiliser used in combination with granulocyte-colony stimulating factor (G-CSF) to mobilise stem cells into peripheral blood for collection and autologous transplantation. It is standard-of-care in haemato-oncology, particularly for patients with multiple myeloma and non-Hodgkin lymphoma undergoing transplant, the company said in a statement. This is the first marketing authorisation the company secured for Plerixafor anywhere in the world, it added. Saransh Chaudhary, President, Global Critical Care, Venus Remedies Limited, and Venus Medicine Research Centre CEO, said, "This is our first Plerixafor approval anywhere in the world, and Saudi Arabia is the right market to launch it in". "Plerixafor sits squarely in the kind of therapy class we are building our
Piramal Pharma has said the US health regulator has issued Form 483 with four observations after inspecting its Telangana-based manufacturing plant. The US Food and Drug Administration (USFDA) conducted an inspection of the company's Digwal (Telangana ) based plant from February 9, 2026, to February 13, 2026. At the conclusion of the inspection, the USFDA issued a Form-483, with four observations, Piramal Pharma said in a regulatory filing on Friday. These observations are related to enhancement in procedures and not related to data integrity and indicated to be classified as a VAI (voluntary action indicated), it added. The company is preparing a detailed response to the observations, which will be submitted to the USFDA within the stipulated timelines, the drug maker stated. Piramal Pharma remains committed to maintaining the highest standards of compliance and will work closely with the agency to comprehensively address all the observations, it added. As per the USFDA, Form 48
Pharma companies will no longer ne required to seek a test licence and may proceed with pharmaceutical development upon submitting an online intimation to CDSCO, except in certain cases, as part of broad simplication notified by the Union Health Ministry. Union Health Ministry has notified key amendments to the New Drugs and Clinical Trials (NDCT) Rules, 2019, aimed at simplifying regulatory processes, reducing approval timelines, and enabling faster conduct of clinical research and pharmaceutical development in the country. The amendment is line with the directions of Prime Minister Narendra Modi to reduce regulatory burden and promote Ease of Doing Business, the ministry sais Under the existing regulatory framework, pharmaceutical companies are required to obtain a test licence from the Central Drugs Standard Control Organization (CDSCO) for the manufacture of small quantities of drugs intended for examination, research, or analysis purposes. Through the notified amendments, thi