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Therapeutical category

Oral broad-spectrum cephalosporin

Characteristics

Granules obtained by means of dry compaction of the crystalline powder without adding any excipients. No solvents are used in the process for higher purity and improved odor of the product, with the exception of acetone used for the final product wash. Methanol is used for the side chain activation.

Applications

The product is suitable for the manufacture of solid dosage forms, such as capsules, after addition of excipients.

Regulatory information

EU: EDQM

USA: FDA

Canada: HPB

Brazil: ANVISA

Australia: TGA

India: MoH

Bangladesh: Moh

South Korea: KFDA

Japan: PMDA

China: CFDA

Taiwan: DoH

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