Hot Pursuit     13-Dec-23
Shilpa Medicare gets TGA Australia nod to manufacture oral mouth dissolving films
Shilpa Medicare announced that its Unit VI, Dabaspet, Karnataka has received approval from Therapeutic Goods Administration (TGA), Australia for manufacturing, labeling, packaging and testing of medicinal Oral Mouth Dissolving Films (Wafers).
The said unit is engaged in the manufacture and testing of oral mouth dissolving films and transdermal patches. The unit is approved by MHRA, UK. The approval from TGA, Australia is for “wafer” dosage forms as Over-The-Counter medicines.

The aforementioned unit is supplying Oral Film products to US and other markets. This approval will enable the company to secure approval and market its Oral Film products in Australia.

Oral Mouth Dissolving Film is a technology intensive, niche dosage form which offers significant advantages over conventional oral dosage forms in terms of patient convenience, dosing compliance and quick and effective delivery of drugs. The company has a pipeline of products in this type of dosage form.

Shilpa Medicare is manufacturing of API, Formulation and Development service. Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India.

The company reported consolidated net profit of Rs 1.61 crore in Q2 FY24 as against net loss of Rs 18.66 crore recorded in Q2 FY23. Net sales jumped 19% to Rs 312.98 crore in Q2 FY24 as compared with Rs 262.91 crore posted in Q2 FY23.

The scrip rose 0.98% to Rs 375.50 on the BSE.

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