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Unrestricted (Àå±â ÀÓÇöõÆ®¿ë Á¦Ç°, Long term implant) |
ÀÎü³» Àå±â°£ »ðÀÔ °¡´ÉÇÑ Á¦Ç°À¸·Î ´©½ÇÅ×Å©³î·ÎÁö Á¦Ç°¸¸ÀÌ °®´Â ³ôÀº ½Å·Ú¼º, ¾ÈÀü¼º, Áö¼Ó¼ºÀ» º¸ÀåÇÏ´Â °¢Á¾ ½Ç¸®ÄÜ Á¦Ç°À» º¸À¯Çϰí ÀÖ½À´Ï´Ù. 1993³â ÀÓÇöõÆ®¿ë ½Ç¸®ÄÜÀÌ ¹®Á¦°¡ µÈ ÀÌÈÄ ¸¹Àº Á¦Ç°µéÀÌ ´©½ÇÅ×Å©³î·ÎÁö Á¦Ç°À¸·Î ´ëüµÇ¾ú½À´Ï´Ù. º» Á¦Ç°Àº ¾ö°ÝÇÑ ÅëÁ¦ Á¶°ÇÇÏ¿¡¼ »ý»ê °ü¸®µÇ°í, ÀÌ¹Ì 20³â ÀÌ»ó ÀÇ·á¿ë ½Ç¸®ÄÜ Á¦Ç°À» °ø±ÞÇϰí ÀÖ½À´Ï´Ù. | |
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Restricted (´Ü±â ÀÓÇöõÆ®¿ë Á¦Ç°, Short term implant) |
29ÀÏ ÀÌÇÏ ÀÎü »ðÀÔ¿ë ÀÇ·á¿ë ½Ç¸®ÄÜ Á¦Ç°À» ISO 9001 ÀÎÁõ ±âÁØÀÇ ¾ö°ÝÇÑ Á¦Á¶ °ü¸®·Î USP Class VI ÀÎÁõ Á¦Ç°À» °ø±ÞÇÕ´Ï´Ù. 30³â ÀÌ»óÀÇ ÃÖ°í ¼öÁØÀÇ Á¦Á¶±â¼úÀ» Àû¿ëÇÏ¿© °¡°Ý °æÀï·Â Àִ ǥÁØ Á¦Ç°°ú »ç¿ëÀÚ ¿ä±¸ Á¦Ç°À» °ø±ÞÇϰí ÀÖ½À´Ï´Ù. | |
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Drug Delivery (¾àÁ¦ Àü´Þ ºÐ¾ß Á¦Ç°) |
Àå±â ¹× ´Ü±â ÀÓÇöõÆ® ±â±â ¶Ç´Â ü³» ¹× ü¿Ü Àü´Þ ±â±â, transdermal, transmucosal µîÀÇ ´Ù¾çÇÑ ±â±â¿¡ ¸ÂÃß¾î ¿©·¯ Á¾·ùÀÇ ¾àÁ¦ Àü´Þ ¿ëµµÀÇ Á¦Ç°À» °ø±ÞÇØ µå¸³´Ï´Ù. Drug Master Access Files(DMF)´Â ¹°·Ð European Pharmacopeia Monographs(EPM) ÀڷḦ ÀÌ¿ëÇÏ½Ç ¼ö ÀÖ½À´Ï´Ù. | |
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Skin Care |
ÈÀåǰ ¿ëµµÀÇ Æ¯ÈµÈ ½Ç¸®ÄÜ formulationÀ» Á¦°øÇÕ´Ï´Ù. ¿¬±¸ °³¹ß »Ó¸¸ ¾Æ´Ï¶ó fluorosilicone °ú phenylsilicone polymers, film formers µîÀ» Á¦°øÇÕ´Ï´Ù.
ÀÚ°Ý Á¶°ÇÀ» ¸¸Á·ÇÏ´Â °í°´¿¡°Ô customized formulationsÀ» µ¶Á¡ °ø±ÞÇØµå¸± ¼ö ÀÖ½À´Ï´Ù.
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Simethicone |
Simethicone USP Á¦Ç°À» Á¦°øÇÕ´Ï´Ù. Simethicone USP (100%) ¿Í Simethicone GS (30% Granular Solid) Á¦Ç°À» Á¦Á¶ °ø±ÞÇϰí ÀÖ½À´Ï´Ù. FDA µî·Ï 21 CFR332.10 °ú 21 CFR332.15 ¿¡ µû¸£¸é À̵é Á¦Ç°Àº ¼Ó¾²¸², À§»ê°ú´Ù, »ê¼º ¼ÒȺҷ®, ¼ö¼ú ÈÄ °¡½º ÅëÁõ ÇØ¼Ò¿¡ ¾ÈÀüÇϰí È¿°ú°¡ ÀÖ½À´Ï´Ù. ½Ã¸ÞƼÄÜÀº ¹Ì»ý¹° ¹ßÈ¿ ¶Ç´Â Á¦¾à °úÁ¤¿¡ foam-control ÀÌ ÇÊ¿äÇÑ °æ¿ì¿¡µµ »ç¿ëÇÒ ¼ö ÀÖ½À´Ï´Ù. ¸ðµç Á¦Ç°Àº Active Pharmaceutical Ingredients (APIs)¿ëÀ¸·Î cGMP ±âÁØÇÏ¿¡ Á¦Á¶µÇ°í °ü¸®µË´Ï´Ù. | |
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