Alembic Pharmaceuticals gets USFDA nod for generic acne treatment gel

Alembic Pharmaceuticals has secured final USFDA approval for its generic Dapsone gel, a topical treatment for acne vulgaris. This approval, for the 5% strength, means the company can now market its version, which is therapeutically equivalent to Almirall's Aczone Gel. This development marks a significant step for Alembic in the US market, offering a new option for acne sufferers.

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India’s nutraceutical market set to nearly double to $57 billion by 2030 on preventive health boom

India's health-conscious population is fueling a boom in the nutraceutical market, projected to nearly double to $55-57 billion by 2030. This shift towards preventive care, supported by e-commerce and government initiatives, sees the sector growing at an impressive 10.5% CAGR. While regulatory efforts are strengthening, challenges like consumer awareness and scientific validation persist, yet the industry is poised for significant expansion.

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Health ministry proposes faster approvals for medical device manufacturing licences

The Union health ministry is proposing to significantly cut down the time taken to issue manufacturing licenses for medical devices. Aimed at boosting ease of doing business and ensuring quicker access to quality products, the amendments will reduce timelines for low to high-risk devices. For instance, Class B devices will see a reduction from 140 to 115 days, and high-risk Class C and D devices from 105 to 90 days.

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Strides Pharma sells majority stake in arm Pivot Path for Rs 100 crore

Strides Pharma Science has divested a majority stake in its subsidiary, Pivot Path, for Rs 100 crore to a consortium led by Ascent Capital and Vintage Classic. This strategic move aims to accelerate Pivot Path's growth by infusing Rs 50 crore for future expansion. Strides will retain a 19.95% stake, while the investors will hold 65.05%. The transaction values Pivot Path at Rs 230 crore post-money.

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Shelf-life norms for imported drugs may be relaxed to reduce wastage

India is set to revise rules for imported medicines, proposing a 12-month minimum residual shelf life instead of the current 60% rule. This aims to ease business and reduce wastage, particularly for drugs with longer expiry dates. However, biological and radiopharmaceutical products will retain the stricter 60% requirement due to public health concerns. Other quality and safety regulations remain unchanged.

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Centre set to tighten oversight of pharma packaging materials

India is set to implement a mandatory registration for printed pharmaceutical packaging manufacturers to combat counterfeit drugs. This move follows seizures of fake weight-loss drugs and vaccines, revealing that genuine packaging materials were being diverted and misused abroad.

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India's GLP-1 boom slows amid price war, weak retention

Initial excitement for India's generic weight-loss drugs is fading. Domestic manufacturers are lowering sales targets due to slower-than-expected prescriptions and patient retention. Unexpected price cuts from the innovator, coupled with the high cost of generics for Indian consumers, are impacting adoption. This has led to a wait-and-watch approach for upcoming launches, with a potential revival anticipated later in the fiscal year.

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