Contract manufacturing
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| 1. |
Full spectrum or vertical integration – from API development and manufacture to the development, manufacture, packaging and distribution of final dosage forms. |
| 2. |
API manufacturing – production of substances only including development of registration documentation (ASMF). |
| 3. |
Development and manufacturing of final dosage forms – development of final dosage form technology, product manufacturing, validation of the manufacturing process and analysis methods, development of drug registration documentation (CTD, eCTD format in accordance with EU requirements, as well as drug registration documentation in accordance with CIS country requirements). |
Contract manufacturing helps bringing products to market faster, because of the fact that companies specialising in contract manufacturing usually perform product development, manufacturing, packaging and delivery within a firm timetable in accordance with the JIT system and GDP requirements.
