For injectable manufacturers

Reported by: FDA Haryana

Diclofenac Sodium Injection IP.

According to the government notification, this injection is allowed for veterinary use, and for humans, it should be available in single-dose packaging.

This means it cannot be manufactured in 10ml packaging. Diclofenac in the market is available in single-pack sizes of 1ml, and 3ml only.

Any manufacturer producing it in a 10ml size, even for human use, is not allowed as per Rule 105 of the Drugs Act.

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