Wipro seeks Schedule M exemption for Tumkur plant, regulator to review plea

Wipro has sought relaxation in requirement of Schedule M for specific categories like disinfectants. The product, Maxkleen, has been registered as a drug. The company has asked to allow them to manufacture the product without a drug licence.

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Shukra Pharma gets YEIDA LoI for Rs 600-crore facility

Shukra Pharmaceuticals will establish a Rs 600-crore facility in Greater Noida. This plant will produce advanced surgical robotics and BNCT technology. The project aims to create over 900 direct jobs. A partnership with Borns Medical Robotics Inc. will bring surgical robotics to India. This venture seeks to make high-precision surgery affordable and accessible across India and Asia.

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Alembic Pharmaceuticals gets USFDA nod for generic Parkinson's disease treatment tablets

Alembic Pharmaceuticals has secured a significant approval from the US health regulator. The company's generic version of Carbidopa, Levodopa, and Entacapone tablets, used for Parkinson's disease, has been cleared by the USFDA. This development marks a crucial step for Alembic in the US market.

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Drug regulator steps up oversight on product changes after approval

Drug makers now need government approval for any quality changes to medicines. This applies to alterations affecting a drug's identity, strength, quality, purity, or potency. The regulator is strengthening manufacturing standards through risk-based audits and more inspections. This ensures only safe and effective medicines reach consumers. Manufacturers must inform the drug regulator about changes in manufacturing, packaging, or shelf life.

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Sun Pharma to pump in Rs 500 cr in Assam manufacturing unit

Sun Pharmaceutical will invest Rs 500 crore to establish a new manufacturing plant in Assam. This significant project will create over 500 direct employment opportunities. The company plans to implement the investment in two phases. Discussions covered land, water, power, and skilled manpower. Sun Pharmaceutical will focus on sustainable manufacturing practices.

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Biopharma Shakti: India targets China dependence, patent cliff

India is launching a major initiative to boost its biopharmaceutical manufacturing. This plan aims to reduce reliance on China for crucial drug components. It also seeks to capitalize on upcoming patent expirations of major global drugs. India will focus on becoming a hub for biosimilars and emerging biologics. This strategy will strengthen the nation's pharmaceutical industry on the global stage.

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AstraZeneca gets CDSCO approval for Durvalumab in gastric cancer treatment

AstraZeneca Pharma India has secured approval for Durvalumab. This drug, combined with chemotherapy, will treat gastric and gastroesophageal junction cancer. The approval comes from the Central Drugs Standard Control Organisation. This new treatment offers a perioperative immunotherapy approach for adult patients. It aims to improve survival rates for those with resectable forms of the disease.

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