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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| Manufacturing, Processing Or Holding of Active Pharmaceutical Ingredients (APIs), March 1998 |
| Internet: | http://www.fda.gov/cber/gdlns/active.pdf |
| Origin/Publisher: | Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/cder/guidance |
| Content: | This guideline presents very extensively all GMP requirements of FDA for active ingredients manufacturers today, both for conventional and for biological active ingredients in human and veterinary medicinal products. |
| Status: | Draft |
| Document Type: | FDA guidance for industry |
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