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ParamountParamount Inc. Tokyo, Japan

Manufacturing

How our medicines are made

The route each dosage form takes through the plant, and the tests a batch must pass before it is released.

  • One GMP certificate

    All five production sections operate under one DRAP GMP certificate.

  • Segregated section

    Cephalosporins are made only in a physically separate section with its own air handling.

  • Batch release

    Every batch is tested by QC and released with a Certificate of Analysis.

  • Management systems

    ISO 9001, ISO 14001 and ISO 45001 certified.

  1. 01

    Dispensing

    Each raw material is released by QC, then weighed for the batch under a second person's check.

  2. 02

    Granulation

    The active ingredient and excipients are mixed and granulated so the powder flows and compresses evenly.

  3. 03

    Drying and sizing

    Granules are dried to a set moisture limit and milled to a uniform size.

  4. 04

    Blending

    Lubricant is added and the blend is mixed until the active ingredient is evenly spread through it.

  5. 05

    Compression

    The press forms each tablet to a set weight, hardness and thickness, checked at intervals through the run.

  6. 06

    Coating

    Coated tablets receive a film or sugar coat in a coating pan; uncoated and chewable tablets skip this step.

  7. 07

    Packing

    Tablets are sealed into blister strips, which are coded with the batch number and expiry date.

Release tests for every batch

  • Uniformity of weight
  • Hardness and friability
  • Disintegration
  • Dissolution
  • Assay of the active ingredient
  • Microbial limits

The standard route for this dosage form. Product-specific limits are on each batch's Certificate of Analysis.

Each product page shows the route for that product. More on quality control and assurance →