GMP
GMP ( )... 1 GMP... 36 GMP... 40 GMP... 44... 44 GMP ()... 47... 47 GMP... 55 GMP... 56 GMP... 57 GMP... 58 GMP (10 )... 58 GMP (11 )... 60 GMP (12 )... 62 GMP (13 )... 64 GMP I
( 14 )... 66 GMP (15 )... 68 GMP (16 )... 70 GMP (17 )... 72 GMP (18 )... 73 GMP (19 )... 75 GMP (1 )... 77 GMP (20 )... 80 GMP (21 )... 82 GMP (22 )... 84 GMP (23 )... 86 GMP II
( 24 )... 88 GMP (25 )... 90 GMP (26 )... 92 GMP (27 )... 94 GMP (28 )... 96 GMP (29 )... 98 GMP (2 )... 100 GMP (30 )... 102 GMP (31 )... 103 GMP (32 )... 105 GMP (33 )... 107 GMP III
( 34 )... 109 GMP (35 )...111 GMP (36 )...113 GMP (37 )...115 GMP (38 )...117 GMP (39 )...118 GMP (3 )... 120 GMP (40 )... 122 GMP (41 )... 124 GMP (42 )... 126 GMP (43 )... 128 GMP IV
( 44 )... 130 GMP (45 )... 132 GMP (46 )... 134 GMP (47 )... 136 GMP (48 )... 138 GMP (49 )... 140 GMP (4 )... 142 GMP (50 )... 144 GMP (51 )... 146 GMP (52 )... 148 GMP (53 )... 150 GMP V
( 54 )... 152 GMP (55 )... 154 GMP (56 )... 156 GMP (57 )... 158 GMP (58 )... 160 GMP (59 )... 162 GMP (5 )... 164 GMP (60 )... 166 GMP (61 )... 168 GMP (62 )... 171 GMP (63 )... 173 GMP VI
( 64 )... 175 GMP (65 )... 177 GMP (66 )... 179 GMP (67 )... 181 GMP (68 )... 184 GMP (69 )... 186 GMP (6 )... 188 GMP (70 )... 190 GMP (71 )... 192 GMP (72 )... 194 GMP (73 )... 196 GMP VII
( 74 )... 198 GMP (7 )... 201 GMP (8 )... 203 GMP (9 )... 205 GMP 100... 207 GMP 101... 209 GMP 102...211 GMP 75... 213 GMP 76... 215 GMP 77... 217 GMP 78... 219 GMP VIII
79... 222 GMP 81... 226 GMP 82... 228 GMP 83... 230 GMP 84... 232 GMP 85... 234 IX
GMP ( ) 1 (1998 ) GMP 2 GMP 225 ( * )56, 169. 3 GMP GMP 4 5 0 20% GMP 0 20-40% 1
3 20% 3 20% 3 GMP / * 0301 0302 0401 0402 ( ) 0403 2
0501 * 0502 0601 0602 0603 0604 0701 3
0702 ( ) ( ) 0801 0901 0902 1001 1101 () 1102 () 4
1103 () 1104 1105 1201 1202 1203 1204 5
1205 1206 1301 () 1401 () *1501 () 1502 () 1503 () 1504 6
*1601 () 1602 1603 1604 1701 () 1801 () 100 () 1901 7
() *1902 10,000 () *1903 () () () *2001 *2002 - *2101 8
*2102 *2201 *2202 *2203 *2204 9
*2205 *2206 *2207 *2208 *2209 2210 10
*2211 *2212 (PCR) *2213 (HIV) *2214 *2215 *2216 ( DNA ) *2217 11
( DNA ) *2218 *2219 () () *2220 2221 2301 12
2302 2303 2304 2401 () 2501 2601 13
2701 () 2801 2802 2901 3001 *3002 *3003 14
3101 3102 3103 ( ) 3201 3202 () 3203 15
3204 () 3205 3206 3301 3401 *3402 80 65 4 16
*3403 *3404 6 4 72 3405 3501 3601 3602 3603 17
3604 3701, 3801 3802 *3901 3902 *3903 4001 18
4002 ( ) 4101 4201 *4202 4301 4302 *4401 19
*4402 ( ) 4403 4404 4405 4406 4407 4408 20
( ) 4409 *4410 4411 4501 *4601 *4602 4701 21
4702 () 4703 4704 4801 4901 4902 22
4903 5001 5002 (HIV) 5101 () 5201 23
5202 5203 5204 100,000 () 5301 () 5302 ( ) 5303 24
5304 5305 5401 () 100 () 5501 () 5601 5602 5603 25
*5701 *5702 *5703 ( ) 5801 5901 6001 26
6401 6402 6501 *6601 6602 6701 6702 27
6801 6802 6803 *6901 7001 7002 *7003 28
*7004 *7005 7006 7007 7008 7009 7010 29
7011 7012 7013 7014 7015 7016 7017 30
7018 7019 7020 7021 *7101 7201 7202 31
7203 7301 7401 7402 7403 7404 ( ) 7405 32
*7501 ` 7502 7503 ( ) *7504 *7505 *7506 33
*7507 7508 7509 () 7510 7511 7601 34
7602 7701 7801 7901 7902 8001 35
8101 8102 8201 8301 8401 GMP 1 1.1 GMP ( ) GMP 36
1.2 GMP 2 2.1 GMP GMP 20 2.2 2.3 2.4 2O 3 3.1 20 37
3.2 3.3 3 GMP GMP 4 4.1 4.2 GMP 4.3 GMP 4.4 38
4.5 4.6 4.7 4.8 4.9 4.10 4.11 5 39
20 6 6.1 20 ) 6.2 ( GMP GMP GMP GMP ( ) GMP GMP GMP GMP ( ) GMP 40
41 GMP GMP GMP () ( ) () ( GMP ) () ( ) () ( ) ( ) () ( ) () ( ) () ( )
( ) () ( ) () ( ) ( ) GMP 2 10 ( ) 3 GMP ( ) GMP GMP 42
( ) GMP GMP GMP 3 GMP GMP ( ) GMP ( ) GMP GMP GMP ( ) 43
GMP ( ) 1 2 2 GMP 1 A4 ( 3cm ) 3 44
4 5 GMP 6 ( ) 7 8 9 10 GMP GMP 45
e-mail ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) () () ( GMP ) GMP ( 46
( ) GMP GMP ( ) GMP () ( ) 1 47
2 3 GMP, 4 ( ) 5 6 7 8 GMP A4 ( 3cm, ) 9 2 1 GMP 2 48
( ) 49
50 ( ) ( ) ( ) ( ) ( ) ( ) ( )
51
52
53
54
GMP 55
( ) GMP 2000 / 32000 / 3200 5000 / 500 2 56
GMP CERTIFICATE OF GOOD MANUFACTURING PRACTICES FOR HUMAN DRUGS PEOPLE Certificate No: Manufacturer: Address: Scope of Inspection: S REPUBLIC OF CHINA This is to certify that the above manufacturer Complies with the Practices. requirements of Chinese Good Manufacturing This certificate remains valid until 57
Issued Date: Issueed By: STATE DRUG ADMINISTRATION PRINTED GMP (10 ) GMP GMP ) 20 GMP /B0207 / / / /B0206 ( ) / / -2 /B0208 58
59 / /B0209 / /B0210 / /B0211 / /B0212 / /B0213 / /B0214 / /B0215 / /B0216 / /B0217 / /B0218 / /B0219 / /B0220 / /B0221 /
/B0222 / ( )/B0223 / /B0225 / /B0226 /B0229 / /B0227 / (11 ) GMP GMP 20 GMP / / / /A0144 ( ) / /B0168 60
61 / /B0230 / /B0231 / /B0232 / /B0233 / /B0234 / ( )/B0235 / /B0236 / ( )/B0237 / ( ) ( )/B0238 / ( )/B0239 / /B0240 / /B0241 / (
)/B0242 / /B0243 ( ) / /B0244 / /B0245 / /B0246 / (706 )/B0247 / /B0248 (12 ) GMP GMP 20 GMP / / / /B0249 / /B0250 / /B0251 62
63 / /B0252 / /B0253 / /B0254 / /B0255 / /B0256 / /B0257 / /B0258 / /B0259 / /B0260 / /B0261 / /B0262 / /B0263 / /B0264 / /B0265 / ( )/B0266 / /B0267
/ /B0268 (13 ) GMP GMP ) 20 GMP / / / /B0269 / /B0270 ( ) / /B0271 / /B0272 64
65 / /B0273 / /B0274 / ( )/B0275 / /B0276 / /B0277 / /B0278 / /B0279 / -2 /B0280 / /B0281 - / ( )/B0282 / /B0283 / /B0284 / -2 /B0285 / /B0286
)/B0287 / ( / /B0288 OOO (14 ) GMP GMP ( ) 20 GMP / / ( ) / /B0224 /B0289 /B0290 / / / /B0291 / /B0292 66
67 / /B0293 / /B0294 / /B0295 ( ) / /B0296 / /B0297 / /B0298 / /B0299 / /B0300 / /B0301 / /B0302 / ( )/B0303 / ( )/B0304 / /B0305 /
/B0306 / /B0307 / /B0308 (15 ) GMP GMP 20 GMP / / / /B0309 /B0311 / /B0310 / / ( )/B0313 / ( )/B0315 68
/B0316 /B0317 / / / /B0319 / ( )/B0320 - / ( )/B0321 / /B0322 / /B0323 / ( )/B0324 / ( )/B0325 / ( )/B0326 / /B0328 / /B0329 / /B0330 / /B0331 69
)/B0332 (16 ) / ( GMP GMP 20 GMP /B0333 / / / / ( )/B0334 / /B0335 / ( ) ( )/B0336 / /B0338 / 70
71 /B0340 / /B0341 / /B0342 / ( )/B0343 / -2 ( )/B0344 / ( )/B0345 / /B0346 / /B0347 / ( )/B0348 / /B0349 / ( ) ( ) /B0350 / /B0351 / /B0352 / /B0353
(17 ) / /B0354 GMP GMP 20 GMP / / / /B0355 / /B0356 /B0359 / /B0357 / /B0358 ( ) / / ( )/B0360 / /B0361 72
73 / /B0362 / /B0363 / /B0364 ( )/ ( ) /B0365 ( ) / ( )/B0366 / /B0367 / /B0368 / /B0369 / /B0370 / ( ) /B0371 / /B0372 / /B0373 / /B0374 GMP (18 )
74 GMP 20 GMP / / / /B0375 / /B0376 / /B0377 / /B0378 / /B0379 / ( ) ( )/B0380 ( ) / /B0381 / /B0382 / /B0383 / /B0384 / /B0385
/B0387 /B0389 ) / /B0386 / / /B0388 / / (A (A ) (A )/B0390 / /B0391 / /B0392 / /B0393 / ( )/B0394 (19 ) GMP GMP 20 GMP / / 75
/ /B0395 / ( )/B0396 /B0397 / / /B0398 / /B0399 / /B0400 / (101 102 103 105 B0401 106 107 )/B0401 / /B0402 / /B0403 / ( )/B0404 / /B0405 / ( )/B0406 / 76
/B0407 / /B0408 / ( )/B0409 / /B0410 / /B0411 / /B0412 / /B0413 / ( )/B0414 (1 ) GMP GMP 30 GMP / / / /A0050 77
/A0051 /A0052 /A0053 /A0054 /A0059 /A0060 /A0063 / / / / / /A0055 / /A0056 / /A0057 / /A0058 / / / /A0061 / /A0062 / / /A0064 / /A0065 78
/A0066 /A0067 /A0068 /A0073 / / / / /A0069 / /A0070 / /A0071 / /A0072 / / /A0074 / /A0075 / /A0076 / /A0093 / /A0094 / /A0095 79
(20 ) GMP GMP 20 GMP ) / / / /B0312 / ( )/B0314 / /B0318 / ( ( )/B0327 / /B0415 / ( )/B0416 / /B0417 / /B0418 / /B0419 /B0420 / 80
/B0422 / /B0421 / / /B0423 /B0424 /B0425 / / / /B0426 / /B0427 /B0429 / /B0428 / / /B0430 81
(21 ) GMP GMP 20 GMP / / / ( )/B0431 / r /B0432 /B0433 /B0436 / / /B0435 / / ( )/B0437 / ( )/B0439 / ( )/B0440 82
83 / /B0441 / ( )/B0442 / ( )/B0443 ( ) / ( )/B0444 / /B0445 / /B0446 / /B0447 / /B0448 / /B0427 / /B0428 / /B0429 / /B0430
(22 ) GMP GMP 20 GMP / / / /B0453 / ( )/B0454 / ( )/B0455 ) / ( ( )/B0456 / ( )/B0457 / ( )/B0458 / /B0459 / /B0460 / /B0461 84
85 / ( )/B0462 / /B0463 / /B0464 / /B0466 / /B0465 / /B0467 / alb( ) /B0468 / ( ) ( ) /B0469 / /B0470 / a2a( ) alb( ) /B0474 / 2a( ) ( ) /B0475
(23 ) GMP GMP ( ) 18 GMP / / ( ) / /B0471 / /B0476 / /B0477 / 2a( ) /B0478 / ( )/B0479 /B0480 / / ( ) /B0481 / 86
87 /B0482 / /B0483 / /B0484 / ( ) ( ) /B0485 / /B0486 ( ) / /B0487 ( ) / /B0488 / /B0489 / /B0490 / /B0491 / /B0492 / ( )/B0493 / ( )/B0494
(24 ) GMP GMP 19 GMP / / / ( )/B0472 / ( )/B0473 / ( )/B0495 / ( )/B0496 / ( )/B0497 / ( )/B0498 / ( )/B0499 /B0500 / / ( 88
89 )/B0501 / ( )/B0502 / ( )/B0503 / /B0504 / ( )/B0505 / /B0507 / ( ) (/B0508/ ) / / ( )/B0509 / ( )/B0510 / ( ) ( ) /B0511 / /B0512 / /B0513
(25 ) GMP GMP 20 GMP /B0514 /B0515 /B0516 / / / / / / ( ) /B0517 /B0518 / / 2a 90
á2b/b0519 / / / 2b /B0520 / ( )/B0521 /B0522 / ( ) / /B0523 / ( )/B0524 / /B0525 / /B0526 /B0529 / /B0527 / /B0528 / / 1b ã /B0531 / /B0532 91
/B0533 / / /B0534 (26 ) GMP GMP 20 GMP / / / /B0530 / /B0535 / ( )/B0536 ( ) / /B0537 / /B0538 / ( 92
93 )/B0539 / /B0540 / ( ) /B0541 ( )/ 2a /B0542 / (PCR) /B0543 / ( )/B0544 / /B0545 / /B0546 / /B0547 / /B0548 / /B0549 / /B0550 / /B0551 / ( ) /B0552
/B0553 (27 ) / GMP GMP 20 GMP / / / ( )/B0555 / ( ) /B0556 /B0559 / /B0557 / /B0558 / / /B0560 / ( 94
95 ) /B0561 / ( ) /B0562 / /B0563 / /B0564 / ( )/B0565 / /B0566 / ( )/B0567 / /B0568 / ( )/B0569 / ( )/B0570 / ( )/B0571 / ( ) ( )
/B0572 ( ) / ( )/B0573 / -2 /B0574 (28 ) GMP GMP 20 GMP / / / /B0575 / /B0576 / /B0577 / /B0578 / ( )/B0579 / ( 96
97 )/B0580 / /B0581 ( )/ /B0582 / ( )/B0583 / /B0584 / ( ) /B0585 / ( )/B0586 / ( )/B0587 / /B0588 / ( )/B0589 / ( ) /B0590 / /B0591
)/B0592 / ( / /B0593 / /B0594 (29 ) GMP GMP 20 GMP / / / ( )/B0595 / /B0596 / /B0597 / /B0598 / ( )/B0599 98
99 / ( )/B0600 / /B0601 / /B0602 / /B0603 / /B0604 / ( )/B0605 / /B0606 / ( )/B0607 / ( ) /B0608 / /B0609 / ( )/B0610 / ( )/B0611 / /B0612 / /B0613 / /B0614
100 GMP (2 ) GMP 20 GMP / / / /A0001 / /AO002 / /A0003 / /A0004 / /A0005 / /A0006 / /A0007 / ( )/A0008 / /A0009 / /A0010
101 / /A0011 / /A0012 / /A0013 / /A0014 / /A0015 / /A0016 / /A0017 / /A0018 / /A0019 / /A0020 / /A0021 ( ) / /A0022 / /A0023
(30 ) GMP GMP 20 GMP / / / /B0615 / /B0616 / (, ), /B0617 / /B0618 / /B0619 / /B0620 / /B0621 / /B0622 / /B0623 / ( )/B0624 / /B0625 102
)/B0626 /B0630 / ( / /B0627 505 / /B0628 / / -2 /B0631 / /B0632 / /B0633 /B0634 / / /B0635 (31 ) GMP GMP 103
104 20 GMP / / / - /B0228 / /B0554 / ( )/B0636 / /B0637 / ( )/B0638 / /B0639 / ( )/B0640 / /B0641 / /B0642 / ( ) /B0643 / ( )/B0644 / /B0645 / ( )/B0646
/ /B0647 / /B0648 / ( )/B0649 / ( )/B0650 / /B0651 - / ( )/B0652 / /B0653 (32 ) GMP GMP 20 GMP / / / /B0654 ( ) / ( 105
106 )/B0655 / /B0656 / /B0657 / /B0658 / /B0659 / /B0660 / ( )/B0661 / /B0662 / ( )/B0663 / ( ) /B0664 / /B0665 / ( ) /B0666 / ( )/B0667 /
/B0668 / /B0670 / ( )/B0671 / /B0672 / /B0673 / /B0674 (33 ) GMP GMP 20 GMP / / / /B0675 / /B0676 / ( )/B0677 107
108 / /B0678 ( ) / /B0679 / ( )/B0680 / /B0681 / /B0682 / /B0683 / /B0684 / ( )/B0685 / ( ) /B0686 / /B0687 / /B0688 / /B0689 / ( )/B0690
/ /B0691 / /B0692 / /B0693 / /B0694 (34 ) GMP GMP 20 GMP /B0695 / / / / 2a -2 /B0696 ) / ( // ( )/B0697 / ( 109
110 )/B0698 / /B0699 / ( ) /B0700 / /B0701 / /B0702 / /B0703 / /B0704 / /B0705 / /B0707 / /B0708 / /B0709 / ( ) ( )/B0710 / ( )/B0711 / /B0712 / /B0713 / (
)/B0714 / ( )/B0715 (35 ) GMP GMP 19 GMP / / / (B )/B0716 / /B0717 / /B0718 / - /B0719 /B0720 / / /B0721 111
112 / /B0722 / (PCR) /B0723 / ( )/B0724 / /B0725 / /B0727 / /B0728 / /B0729 / /B0730 / /B0731 / /B0732 / /B0733 / /B0734 / /B0735
(36 ) GMP GMP 20 GMP / / / /B0374 / ( )/B0669 / /B0736 / ( ) ( )/B0737 ( ) / ( A)/B0738 / /B0739 / 113
114 /B0740 / /B0741 / /B0742 / /B0743 / ( )/B0744 / ( )/B0745 / /B0746 / /B0747 / /B0748 / ( ) /B0749 / /B0750 / /B0751 / /B0752 / /B0754
(37 ) GMP GMP 19 GMP / / / /C0755 / /C0756 / /C0757 / ( )/C0758 / /C0759 / /C0760 / /C0761 / /B0762 //B0763 / 115
( )/C0764 /C0765 /C0767 / / / ( ) /B0768 /C0769 / / /C0770 / /C0771 /C0775 / /B0772 / /B0773 / /C0774 / 116
(38 ) GMP GMP 19 GMP / / / ( ) /B0776 / ( ) ( )/B0777 /C0779 / /B0778 / / ( ) ( )/B0780 / /C0781 / /C0782 / /C0783 / ( ) /C0784 117
118 / /C0785 - ( ) / /C0786 ( ) / /C0787 / /C0788 / /C0789 / /C0790 / /C0791 / /C0792 / /C0793 / /C0794 / /C0797 GMP (39 ) GMP 20 GMP
119 / / / /C0506 / /C0629 / /C0706 / /C0795 / ( )/C0798 / ( ) ( )/C0799 / 1b -2 /C0800 / /C0801 / /C0802 / ( )/C0803 / /C0804 / -2 /C0805 / /C0806
120 / ( )/C0808 / /C0810 / /C0811 / /C0812 / /C0813 ( ) / ( ) /C0814 / /C0815 GMP (3 ) GMP 20 GMP / / / /A0024 / /AO025 / /A0026
121 / /A0027 / /A0028 / /A0029 / /A0030 / ( )/A0031 / /A0032 / ( )/A0033 ( ) / /A0034 / ( )/A0035 / /A0036 ( ) / /A0037 / ( )/A0038 / ( )/A0039 / ( )/A0040 / ( )/A0041
/ /A0042 // / ( )/A0043 /A0044 / / /A0045 (40 ) GMP GMP - 20 GMP / / - / /C0817 / /C0818 / 122
123 /C0819 / /C0820 / /C0821 / - /C0822 / /C0823 / /C0824 / /C0825 / /C0826 / /C0827 / /C0829 / 2b /C0831 / /C0832 / /C0833 / ( )/C0834
)/C0835 /C0837 / ( / /C0836 (+) / / /C0838 (41 ) GMP GMP 19 GMP / / / ( ) /B0339 / /C0796 ( ) / ( ) /C0828 124
/C0839 / / /C0840 /C0841 /C0844 /C0845 () / / /C0842 / /C0843 / / / /C0846 / /C0847 / /C0848 / () /C0849 /C0851 / /C0850 / / ( 125
) /C0852 / ( )/C0853 ( ) / /C0854 / /C0855 (42 ) GMP GMP 19 GMP / / / /C0816 ( ) / /C0856 / ( ) /C0857 126
/C0858 /C0862 ( ) / / /C0859 / /C0860 / /C0861 / / /C0863 1/ /C0864 / ( )/C0865 / /C0866 / /C0867 / ( ) (CHO ) ( Vi b A A+C ) ( A )/C0868 / - /C0869 127
/C0870 ( ) / / /C0871 / 2b - /C0872 /C0873 / / /C0876 / / (43 ) GMP GMP ( ) 20 GMP / / 128
/C0753 ( ) / / /C0776 / /C0807 / ( ) /C0809 2b / /C0830 / -2 / / ( )/C0874 / ( )/C0875 / ( )/C0877 / /C0878 / ( ) /C0879 / /C0880 / /C0883 / /C0884 129
/C0885 / ( ) / /C0886 /C0887 / / ( ), ( )/C0888 / /C0889 /C0890 / /C0892/ (44 ) GMP GMP 20 GMP 130
131 / / / /C0881 / /C0891 / ( )/C0893 / /C0894 / /C0895 / ( )/C0896 / /C0897 / /C0898 / /C0899 / /C0900 / /C0901 / /C0902 / (
)/C0903 ( ) / /C0904 / ( )/C0905 / ( )/C0906 /C0908 / / /C0909 / /C0910 / ( ) /C0911 (45 ) GMP GMP 19 GMP / / 132
133 / /B0438 / /C0907 / ( ) /C0912 / /C0913 / /C0914 / /C0915 / 2b /C0916 / ( )/C0917 / ( )/C0918 / ( ) /C0919 / ( )/C0920 / /C0921 / /C0923
/C0924 /C0925 / / / 2b ( )/C0926 / /C0927 ( ) / /C0928 /C0931 / /C0929 / (46 ) GMP GMP 19 GMP 134
/C0922 / / / / ( )/C0930 / /C0933 /C0936 /C0937 / /C0934 / / / /C0938 /C0939 /C0940 /C0941 / / / / /C0942 135
/C0943 / / /C0944 /C0946 / / -8 /C0947 / /C0948 / /C0949 / /C0950 / /C0951 / ( )/C0952 (47 ) GMP GMP 136
137 20 GMP / / / /C0953 / /C0954 / /C0955 / /C0956 / /C0957 / ( ) /C0958 / /C0959 / (Vero ) /C0960 / ( C)/C0961 / /C0962 / ( )/C0963 / /C0964
B12)/C0965 / ( / /C0966 / /C0967 / ( )/C0968 /C0969 ( ) / / /C0970 / /C0971 / /C0972 (48 ) GMP GMP 19 GMP / / / ( )/B0485 138
139 / ( )/C0932 / /C0945 / /C0973 / /C0974 / /C0975 / /C0976 / /C0977 / /C0978 / /C0979 / /C0980 / ( ) /C0981 / /C0982 / /C0983 / /C0984
/ /C0985 / /C0986 / /C0988 / /C0989 / /C0990 (49 ) GMP GMP 20 GMP / / / /C0991 / /C0992 / /C0993 / 140
141 /C0994 / /C0995 / /C0996 / /C0997 / ( ) /C0998 / ( ) ( ) /C0999 / /C1000 / /C1001 / /C1002 / /C1003 / ( )/C1004 / ( )/C1005 / /C1006
142 / /C1007 / /C1008 / /C1009 / /C1010 GMP (4 ) GMP 20 GMP / / / ( )/A0046 / ( )/AO047 ( ) / /A0048 /
143 /A0049 / /A0077 / ( )/A0078 / ( )/A0079 / /A0080 / /A0081 / /A0082 ( ) / /A0083 / /A0084 / /A0085 / /A0086 / /A0087 / ( )/A0088
/ /A0089 / ( )/A0090 / /A0091 / /A0092 /A0096 / / /A0097 (50 ) GMP GMP 18 GMF / / / /C1011 / /C1012 / /C1013 144
145 / /C1015 / /C1016 / /C1017 / ( ) /C1018 / /C1019 / /C1020 / /C1021 / /C1022 / /C1023 / /C1024 / ( ) /C1025 / /C1026 / /C1027 / ( ) /C1028
/C1029 / / /C1030 /C1031 / (51 ) GMP GMP 19 GMP / / / ( )/B0260 /C0935 / / ( )/C1014 146
147 / /C1032 / /C1033 / /C1034 / /C1035 / /C1036 / /C1037 ( ) / /C1038 / ( )/C1039 / ( )/C1040 / /C1043 / /C1044 / /C1045 / /C1046 ( ) /
/C1047 /C1049 / ( ) ( ) / /C1051 / /C1052 (52 ) GMP GMP 20 GMP / / / ( )/B337 / /C0891 / ( )/C1053 148
)/C1054 /C1055 /C1056 / ( / / / /C1058 / ( )/C1059 / ( )/C1060 /C1061 / / ( ) /C1062 /C1063 / / -2 /C1064 / /C1065 / ( 149
)/C1066 / ( )/C1067 / /C1068 / /C1069 / /C1070 / /C1071 (53 ) GMP GMP 20 GMP / / / ( ) /C1072 / ( )/C1073 150
151 / /C1074 / /C1075 / /C1076 / /C1077 / /C1079 / /C1080 / /C1081 / /C1082 / /C1083 / /C1084 ( ) / /C1085 / 2a /C1086 / /C1087 /
/C1089 /C1088 / ( ) / /C1090 / /C1091 / /C1092 (54 ) GMP GMP 20 GMP / / / /C1093 / /C1094 / 152
153 /C1095 / /C1096 / /C1097 / /C1098 / /C1099 / /C1100 ( ) / /C1101 / /C1102 / /C1103 / /C1104 / ( ) /C1105 / /C1106 / /C1107 / /C1108
154 / /C1109 / /C1110 / ( )/C1111 / /C1112 GMP (55 ) GMP 20 GMP / / / /C1113 / /C1114 / /C1115 / /C1116
155 / /C1117 / ( )/C1118 / /C1119 / ( )/C1120 / ( )/C1121 ( ) / /C1122 / /C1123 / /C1124 / /C1125 / /C1126 / /C1127 / ( )/C1129 / /C1130 / /C1131 / (
)/C1132 / /C1134 / ( ) /C1137 / /C1139 (56 ) GMP GMP 20 GMP / / / /C1140 / ( L- )/C1141 156
157 / /C1144 / /C1145 / /C1147 / ( )/C1148 / /C1149 / /C1150 / /C1151 / /C1152 / /C1153 / /C1154 / /C1155 / ( )/C1156 / /C1157
/C1159 /C1160 /C1161 / /C1158 / / / / /C1162 (57 ) GMP GMP 20 GMP / / / /C1133 158
159 / ( ) /C1135 / /C1138 / /C1146 / /C1163 / /C1164 / /C1165 / ( ) ( )/C1166 / /C1167 / ( )/C1168 / /C1170 / /C1171 / /C1172 / /C1173
/ /C1174 / ( ) /C1175 / /C1176 / /C1177 / /C1178 / /C1179 (58 ) GMP GMP 19 GMP /C1180 / / / 160
161 / ( ) ( )/C1181 C1182 / /C1183 / /C1184 / /C1185 / /C1186 / /C1187 / ( B12 )/C1188 / /C1189 / /C1190 ( ) / /C1191 /
162 /C1192 / /C1193 / /C1194 / /C1195 / /C1196 / /C1197 / /C1198 / ( ) /C1199 GMP (59 ) GMP 20
163 GMP / / / /C0882 / /C1041 / /C1042 / ( ) /C1048 / /C1050 / /C1057 / /C1128 / /C1136 / ( )/C1143 / ( )/C1200 / ( )/C1201 / /C1202
/C1203 / / ( ) /C1204 / /C1205 ) / ( ( )/C1206 / /C1207 / ( )/C1208 / /C1209 / /C1210 (5 ) GMP GMP 20 GMP 164
165 / / / /A0098 / /A0099 / /A0100 / ( )/A0101 / /A0102 / /A0103 / /A0104 / /A0105 / /A0106 / /A0107 / /A0108 / /A0109 / /A0110 / /A0111 / /A0112 / /A0113
/A0314 /A0116 / /A0115 / / / /A0117 /A0119 /A0120 / /A0118 / ( ) / (60 ) GMP GMP 20 GMP 166
/ / / ( )/C1211 /C1212 /C1213 / / / ( )/C1214 / /C1215 / ( )/C1216 /C1217 / / /C1218 / /C1219 / /C1220 /C1221 / 167
/C1222 / / /C1223 / /C1224 /C1226 / /C1225 / / /C1227 / ( )/C1228 / ( )/C1229 / /C1230 (61 ) GMP 168
169 GMP 20 GMP / / / /C1231 / /C1232 ( ) / /C1233 / - 2 /C1234 / ( )/C1235 / 2a á2b /C1236 / /C1237 ( ) / /C1238 / /C1239 / /C1240
170 / ( ) /C1241 / /C1242 / /C1243 / /C1244 / /C1245 / (Vero ) ( )/C1246 / ( ) ( )/C0987 / /C1248 / ( )/C1249 / ( )( )/C1250
(62 ) GMP GMP 20 GMP / / / /C1251 / ( ) /C1252 C1253 / ( )/C1254 / /C1255 / /C1256 / /C1257 / ( )/C1258 / ( 171
172 )/C1259 / /C1260 / /C1261 / /C1262 / ( )/C1263 / /C1264 / /C1265 / /C1266 / /C1267 / ( ) /C1268 / /C12369 / ( )/C1270
(63 ) GMP GMP 20 GMP / / / ( )/D1271 /D1272 /D1274 /D1275 / / /D1273 / / / /D1276 / ( ) ( )/D1277 173
174 / /D1278 / ( ) /D1279 / /D1280 / /D1281 / ( )/D1282 / /D1283 / /D1284 / /D1285 / /D1286 / /D1287 / ( )/D1288 / ( B1 )/D1289
/D1290 (64 ) / GMP GMP ( ) 19 GMP ) /D1292 / / ( ) / ( /D1291 / / /D1293 / /D1294 / 175
176 /D1295 / /D1296 / D1297/D1297 / /D1298 / /D1299 / ( )/D1300 ( ) / ( C C )/D1301 / ( ) /D1302 / /D1303 / /D1304 / /D1305 / ( )/D1306
/ ( ) /D1307 ) / ( ( ) /D1308 / /D1309 D1310 (65 ) GMP GMP 18 GMP / / / ( ) /D1311 D1312 / /D1313 177
178 / /D1314 / ( )/D1315 / ( ) /D1316 / ( )/D1317 / /D1318 / /D1319 / /D1320 / /D1321 / /D1322 / ( B6)/D1323 /
D1324 D1325 / /D1326 /D1327 / / /D1328 /D1329 / / ( B ) ( ) /D1330 (66 ) GMP GMP 19 GMP 179
180 / / / ( ) /D1331 / ( ) ( ) /D1332 D1333 / ( )/D1334 / /D1335 / /D1336 / ( )/D1337 / /D1338 / /D1339 / /D1340 / /D1341 /
181 /D1342 / ( ) /D1343 / /D1344 / ( )/D1345 / /D1346 / /D1347 / ( )/D1348 / /D1349 / /D1350 GMP (67 ) GMP
182 20 GMP / / / /D1351 / ( B12 )/D1352 / /D1353 / /D1354 / /D1355 / ( ) /D1356 / ( ) /D1357 / /D1358 / 2b /D1359
183 / 2b ( ) /D1360 / /D1361 / /D1362 / /D1363 / ( ) /D1364 / /D1365 / ( ) ( )/D1366 / /D1367 / ( ) /D1368 / /D1369 / ( )/D1370
(68 ) GMP GMP 20 GMP / / / ( )/D1371 / /D1372 / /D1373 / D1374/D1374 / /D1375 / /D1376 / 184
185 /D1377 / D1378/D1378 / /D1379 / /D1380 / /D1381 / /D1382 / ( )/D1383 / /D1384 / /D1385 / /D1386 / /D1387 / /D1388 / ( )/D1389 /
/D1390 (69 ) GMP GMP 20 GMP / / / ( ) /D1391 /D1393 / /D1392 / / /D1394 / /D1395 / - /D1396 / ( ) 186
187 /D1397 / ( ) /D1398 / ( )/D1399 / /D1400 / ( )/D1401 / /D1402 / /D1403 / /D1404 / /D1405 / /D1406 / (Vero )/D1407 / ( ) ( ) /D1408 / /D1409
)/D1410 (6 ) / ( GMP GMP 20 GMP /A0122 / / / /A0121 / / /A0123 / /A0124 / /A0125 / / ( ) / E 188
189 /A0126 / /A0127 / ( )/A0128 / ( )/ / /A0129 / /A0130 / /A0131 / /A0132 / /A0133 / /A0134 / /A0135 / ( )/A0136 / /A0137 / /A0138 / (
/A0140 )/A0139 / (70 ) GMP GMP 19 GMP / / / ( )/D1411 / ( ) /D1412 / /D1413 / /D1414 190
191 / D1415/D1415 / /D1416 / /D1417 / /D1418 / /D1419 / ( ) /D1420 / /D1421 / /D1422 / /D1423 / ( ) /D1424 / ( ) /D1425 / ( )/D1426 ( ) / /D1427
2b /D1428 / / /D1429 / /D1430 (71 ) GMP GMP 20 GMP /D1431 / / / / /D1432 / /D1433 192
193 / /D1434 / /D1435 / ( ) /D1436 / /D1437 / /D1438 / /D1439 / ( )/D1440 / ( ) /D1441 / /D1442 / ( )/D1443 / /D1444 / /D1445 / /D1446
/ /D1447 / [ ( ) 20 40] /D1448 / /D1449 /D1450 / (72 ) GMP GMP 20 GMP / / / /D1451 / /D1452 194
195 / /D1453 / /D1454 / ( )/D1455 / /D1456 / /D1457 / /D1458 / /D1459 / /D1460 / /D1461 / /D1462 / /D1463 / /D1464 / /D1465 / ( )
/D1466 /D1467 / / /D1468 / /D1469 / /D1470 (73 ) GMP GMP 19 GMP /D1471 / / / 196
197 / /D1472 / /D1473 / /D1474 / /D1475 ( ) / /D1476 / ( -1) /D1477 / /D1478 / /D1479 / /D1480 / ( ) /D1481 / ( ) ( )/D1482 / ( )/D1483
198 / /D1484 / /D1485 / ( )/D1486 / ( ) /D1487 D1488 / /D1489 / ( ) /D1490 GMP (74 ) GMP
199 19 GMP / / / ( )/D1491 / /D1492 / /D1493 / ( ) ( )/D1494 D1495 / (201 )/D1496 / /D1497 / ( )/D1498 / /D1499 / /D1500 / /D1501
200 / /D1502 / /D1503 / ( )/D1504 / /D1505 / ( K1 K4 B4 ( ) )/D1506 / /D1507 / /D1508 / /D1509 / ( )/D1510
(7 ) GMP GMP 2O GMP /A0143 /A0145 /A0146 / / / /A0141 / /A0142 / / / / / / /A0147 ( ) / /A0148 / /A0149 / /A0150 / /A0151 / /A0152 201
/A0153 /A0154 /A0156 / / / /A0155 / / /AO157 /A0158 / / /A0159 /A0160 ) / / / / /A0161 / ( )/A0162 ( ) ( / ( )/A0165 202
(8 ) GMP GMP 20 GMP / / / /A0163 / /A0164 / /A0166 /B0167 )/ / /B0169 / /B0170 / /B0171 / /B0172 203
204 / /B0173 / ( )/B0174 / /B0175 ( ) / ( )/B0176 / /B0177 / ( )/B0178 / /B0179 / /B0180 / / / ( )/B0181 / /B0182 / /B0183 / /B0184 / /B0185
(9 ) GMP GMP 20 GMP ( ) B0186 ( ) B0187 B0188 B0189 B0190 - B0191 B0192 205
206 - B0193 B0194 B0195 B0196 B0197 B0198 B0199 B0200 B0201 B0202 B0203 B0204
100 B0205 GMP GMP 17 GMP / / / /D2014 / /D2014 / ( )/D2016 / /D2017 / /D2018 / ( ) /D2020 207
208 / /D2021 / ( )/D2022 / ( )/D2023 / /D2024 / ( )/D2025 / ( ) ( )/D2027 / /D2028 / ( )/D2029 / /D2030 / /D2031 / /D2032 / ( )/D2033 / ( )
/D2034 / /D2035 101 GMP GMP 18 GMP / / / /D2036 / /D2037 / ( )/D2038 / ( ) /E2039 / ( 209
210 )/E2040 //E2041 / /E2042 ( ) / /E2043 / /E2044 / /E2045 / /E2046 / ( )/ / /E2047 / /E2048 / /E2049 / /E2050 / ( )/E2051 / ( )/E2052
/ /E2053 / /E2054 / /E2055 102 GMP GMP 15 GMP / / / /E2056 / /E2057 /E2058 / / ( 211
)/E2059 / ( ) /E2060 / ( ) /E2061 1)/E2063 / /E2062 / ( / /E2064 / /E2065 / /E2066 / /E2067 / ( ) /E2068 / ( )/E2069 () / /E2070 / /E2071 / /E2072 / ( 212
)/E2073 ( ) / /C1142 /D1578 / 75 GMP GMP 18 GMP /D1511 / / / / /D1512 / ( ) /D1513 213
214 ( ) / ( E1)/D1514 / /D1515 / /D1516 / /D1517 D1518 / ( )/D1519 ( ) / ( )/D1520 / ( )/D1521 / /D1522 / /D1523 / /D1524 D1525 / /D1526
215 / /D1527 - / /D1528 / ( ) /D1529 / /D1530 GMP 76 GMP 19 GMP / / / /D1531 / ( )/D1532
216 / /D1533 / ( )/D1534 / ( ) ( ) /D1535 / ( ) /D1536 / ( ) /D1537 / /D1538 / ( E1 ) ( )/D1539 D9540 / ( )/D1541 / ( )/D1542
/ /D1543 / /D1544 /D1545 / / ( )/D1546 / /D1547 / /D1548 / /D1549 / /D1550 77 GMP GMP 17 217
GMP / / / /D1551 / ( ) ( ) /D1552 / ( ) /D1553 / /D1554 ( ) / ( ) [ ( )/D1555 /D1557 D1556 / / ( ) /D1558 / /D1559 / ( )/D1560 / ( ) /D1561 218
/ /D1563 / /D1562 / /D1564 / ( ) ( ) /D1565 D1566 / ( ) ( ) ( )/D1567 D1568 / /D1569 / /D1570 78 GMP GMP 18 GMP 219
220 / / / ( ) ( )/D1571 / ( ) /D1572 D1573 / /D1574 / ( ) ( )/D1575 / ( )/D1576 / ( ) /D1577 / ( )/D1579 / ( )/D1580 /
221 /D1581 D1582 / /D1583 / /D1584 / /D1585 ( ) / /D1586 / /D1587 / /D1588 / ( ( A ) /D1589 / /D1590 / /D1591
79 GMP GMP 19 GMP / / / /D1592 / ( )/D1593 / ( )/D1594 / /D1595 /D1596 /D1597 /D1598 / / / / 222
223 /D1599 / ( ) /D1600 / /D1601D1602 / /D1603 / /D1604 / /D1605 / ( )/D1606 / /D1607 / ( ) ( )/D1608 / ( )/D1609 / /D1610 / /D1611
GMP 80 GMP 19 GMP / / ( )/D1612 / ( )/D1613 / /D1614 D1615 / ( ) ( ) /D1616 / ( 224
225 )/D1617 / /D1618 / /D1619 / /D1620 / /D1621 / /D1622 / /D1623 / /D1624 / ( )/D1625 / ( ) /D1626 / /D1627 / ( ) ( ) /D1628 ( ) /
( ) /D1629 / /D1630 / ( )/D1631 81 GMP GMP 19 GMP / / / ( ) /D1632 /D1633 / / /D1634 / 226
/D1635 / ( )/D1636 / /D1637 / ( ) /D1638 / ( )/D1639 /D1640 / / /D1641 D1642 ) / ( /D1643 / ( )/D1644 / ( )/D1645 / /D1646 / ( )/D1647 227
-8 /D1648 / / ( )/D1649 / /D1650 / /D1651 82 GMP GMP 19 GMP / / / /D1652 / ( )/D1653 / /D1654 / ( )/D1655 228
229 / /D1656 / /D1657 / /D1658 ( )/ ( ) /D1659 ( ) / ( ) ( )/D1660 / /D1661 / /D1662 / /D1663 / /D1664 / /D1665 / /D1666 / ( )/D1667 / ( ) (
) /D1668 / ( )/D1670 - / ( )/D1671 83 GMP GMP 17 GMP ) /D1673 / / / ( /D1672 / / 230
231 /D1674 D1675 / ( )/D1676 / ( )/D1677 / ( )/D1678 / /D1679 / /D1680 / /D1681 / /D1682 / /D1683 / /D1684 D1685 / /D1686 D1687 /
/D1688 /D1690 / /D1689 / / /D1691 84 GMP GMP 19 GMP / / / ( )/D1692 / ( ) /D1693 / 232
233-2b á-2b /D1694 ( ) / /D1695 / /D1696 / ( ) ( ) /D1697 / ( ) /D1698 / /D1699 / /D1700 / ( ) /D1701 / ( )/D1702 / /D1703 / /D1704 / /D1705 /
/D1706 / /D1707 / /D1708 / ( ) /D1709 / /D1710 D1711 85 GMP GMP 20 GMP / / / /D1712 / 234
235 /D1713 / ( )/D1714 / ( ) ( )/D1715 / /D1716 / ( )/D1717 / ( ) ( )/D1718 ( ) / /D1719 / ( )/D1720 / /D1721 / /D1722 / /D1723 / (CHO ) /D1724 / ( ) /D1725 / -2b /D1726
(Vero )/D1727 /D1728 / ( ) / / /D1729 / /D1730 / /D1731 236