Shilpa Medicare Bengaluru unit gets TGA Australia nod for manufacturing medicinal Oral Mouth Dissolving Films
This approval will enable the company to secure approval and market its Oral Film products in Australia.
Karnataka: Shilpa Medicare Limited, Unit VI, Dabaspet, Bengaluru, Karnataka, India has received approval from TGA, Australia for the manufacture, labeling, packaging and testing of medicinal Oral Mouth Dissolving Films (Wafers).
This Unit of Shilpa Medicare is engaged in the manufacture and testing of Oral Mouth Dissolving Films and Transdermal Patches.
The Unit is approved by MHRA, UK. This approval from TGA, Australia is for “wafer” dosage forms as Over-The-Counter medicines. This 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.
Medical Dialogues team had earlier reported that Shilpa Medicare’s finished dosage form manufacturing facility, Unit IV, situated at Pharma SEZ, Jadcherla, Telangana state hasd successfully closed out a GMP Inspection from TGA, Australia.
Read also: Shilpa Medicare Jadcherla facility clears TGA, Australia GMP inspection
Shilpa Medicare Limited started its operations as an API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of API and Formulation globally in different regulated markets.
Read also: Shilpa Pharma Lifesciences Unit II Raichur facility clears PMDA Japan GMP inspection
