● Clear audit scope and highlighted
emphasis
● Efficient and scientific site quality
audit
● Complaint with the fact and objective
audit report
PHEXCOM- professional audit service provider for pharmaceutical raw material (APIs ,excipients, intermediates)and packaging material.Started audit service since 2012. Till now our audit team has 15 contracted GMP auditors and comsultants with more than 20 years experience in quality management, among which 6 persons are QP experts. They are based in China,Europe, USA and India．
Raw Material Suppliers Aduited by Phexcom >>
Suppliers
Audit locations
Audit products
| 1 | The Changzhou, Ke Laibo Chemical Co., Ltd. | The Jiangsu Suqian ecological Chemical Technology Industrial Park ZTE northbound section | 2,4-dichloro acetophenone |
| 2 | Zhejiang Lantian Environmental Protection Hi-Tech Co., Ltd. | Xiasha Economic Development Zone in Zhejiang Province on the 5th Avenue South | 1,1,1-trifluroro-2-chloroethane(R133a) |
| 3 | Zhejiang Weihua Chemical Co., Ltd. | 3 Weishan Town, Dongyang City, Zhejiang Province, Industrial Road, No. 128 | 3-hydroxybenzotrifluoride (SKF-4480) |
| 4 | Of Lianyungang Jinshuai Pharmaceutical & Chemical Co., Ltd. | The Lianyungang City Guanyun Harbor industrial park Weijiu of Road south | 2-butyl-3-(3,5-diiodo-4-hydroxybenzoyl)benzofuran |
| 5 | Jiangyan research Fine Chemical Co., Ltd. | Development Zone, Jiangyan City, Jiangsu Province, Yangzhou Road | 2,4 - dichloro-acetophenone |
| 6 | Xi'an is too Bao Pharmaceutical & Chemical Technology Co., Ltd. | Huxian | 2 - amino - 4,6 - dichloro - 5 - formamido-pyrimidine(FADCP) |
| 7 | Jiangsu Branch of the Pharma & Chemical Co., Ltd. | Hangzhou, Zhejiang | (2S, 5R)-5-fluorocytosine-1-yl-[1,3]-oxathiolane menthyl 2- carboxylic acid |
| 8 | he Yingkou Sanzheng Organic Chemical Corporation | Yingkou, Liaoning | 2 - diazabicyclo (2,2,1) hept - 5 - en - 3 - one |
| 9 | The Ningbo wusheng Chemical Co., Ltd. | Ningbo, Zhejiang | (2S, 3aS, 7aS) - octahydro-indole-2 - carboxylic acid |
| 10 | Nantong Hales Pharmaceutical Co., Ltd. | Nantong, Jiangsu | 4-dichloro-s-fluoropyrimidine |
| 11 | Basailiya Pharmaceutical (China) Co., Ltd. | Nantong, Jiangsu | (-)-corey alcohol benzoate |
| 12 | hangzhou Watson Fine Chemicals Co., Ltd. | Changzhou, Jiangsu | 3-Amino-4-pyrazolecarboxamide hemisulfate |
| 13 | 3-Amino-4-pyrazolecarboxamide hemisulfate | The Anhui Huainan economic development zone | Microcrystalline cellulose |
| 14 | PCG Customs and Capsule Co., Ltd. | India | The capsule and DVDC packaging materials |
| 15 | BASF SE | Carl-Bosch-Str.38, 67056 Ludwigshafen Germany | Polyxoyl 40 Hydrogenated castor Oil,Povidone, kollicoat IR coating system, Soluplus, Polyvinylalcohol-Polyethylene, Crospovidone, Poly(vinyl Acetate) Dispersion 30 persent, Copovidone, Pre-mixed Excipient of lactose providone and crospovidone |
| 16 | Shangrao Jinfeng Medicine chemical CO., Ltd. | Jintan Venture Base, Chating Town, Shangrao, Jiangxi, China.334114 | 3-Carbamoymethyl-5-methylhexanoic Acid(CAS#181289-15-6) |
| 17 | Shandong Zouping Dazhan New Materials Co., Ltd. | No.1 Ganyuan Road, Linchi Town, Zouping County, Shandong Province, China. | Cinacalcet Intermediates-3- (3- (Trifluoromethyl)phenyl)propanal(CAS#21172-41-8)-(R )-1-(Naphthalen-1-yl)ethanamine(CAS#3886-70-2)Dronedarone Intermediates-n-(3-Chloropropyl)dibutylamine(CAS#36421-15-5)2-Butyl-3-(4-Hydroxybenzoyl)-5-Nitrobenzofuran(CAS#141645-16-1) |
| 18 | Zhengzhou Ruipu Biological Engineering CO., Ltd. | Intersection of Hongsong Road and West Wutong Street, Hi-Tech Industries | PNS-San Premix |
| 19 | Qingdao Hualilang New Technology Industrial CO., Ltd. | No. 3316 Sansha Road, Huangdao District (Former Jiaonan), Qingdao, Shandong, China | Folic Acid, FCC grade |
| 20 | Hongrui Fine Chemical Co.,Ltd. | Chengnan Industrial Zone, Jixi County, Anhui, China 245300 | 5-Chloro-2-Pentanone (CAS#5891-21-4) |
| 21 | Hongrui Fine Chemical Co.,Ltd. | Chengnan Industrial Zone, Jixi County, Anhui, China 245300 | 5-Chloro-2-Pentanone (CAS#5891-21-4) |
| 22 | Weifang Binhai Petro-chem Co.,Ltd. | Hanting Ocean Chemical Development Zone, Weifang City, Shandong Province, China,262737 | DIMETHYL MALONATE(CAS#108-59-8) |
| 23 | ChangYi XinXing Technology Development Co., Ltd. | Binhai (Xiaying) Economic Development Zone, Changyi City, Shandong Province, China | Di-tert-butyl dicarbonate(Diboc)(CAS#24424-99-5) |
| 24 | Hebei Chengxin Co., Ltd． | Yuanzhao Road, Yuanshi County, Shijiazhuang City, Hebei Province, China | Triethyl Orthoformate |
| 25 | Hangzhou Read Chemical Co., Ltd | Room 5F,2-1 Xiyuanjiu Road, West Lake Tech.Zone, Hangzhou-310030,China | 4-N-Acetyl-amino-cyclohexanone |
| 26 | Linshu Huasheng Chemical Co., Ltd | Jiaolong Town, Linshu County, Shandong Province, China, 276708 | Triethyl Orthoformate |
| 27 | Jiangsu Zhenfang Pharm-chemical Co., Ltd | West side of yannan Avenue, Salt Chemical Industry Zone, Huai’an City, Jiangsu Province, China, 223100 | p-Chlorobezaldehyde |
| 28 | Jiangsu Cale New Materials Co., Ltd | Touzeng Village, Binhuai Town, Binhai County, Yancheng, Jiangsu Province, China (Zhongshan 3rd Road, Binhai Economic Development Zone, Jiangsu Province) 224000 | imidazole |
| 29 | Jiangxi Tianxin Pharmaceutical Co., Ltd | Le’anjiang Industrial Zone, Leping, Jiangxi 333300, China. | Folic Acid, FCC grade |
| 30 | Chengdu Shengnuo Biopharm Co., Ltd | No. 258, Segment 1, industrial Road, Dayi County, Chengdu, Sichuan 611330, China | Bivalirudin API |
| 31 | Sichuan Neijiang Huixin Pharmaceutical Co., Ltd | No. 188 Linchang Road, Baima Town, Neijiang, Sichuan 641005, China | Ergocalciferol ( Vitamin D2) API |
| 32 | Changzhou Niutang Chemical Plant Co., Ltd. | No.88 Yanzheng Road, Niutang Town, Wujin Distract, Changzhou, Jiangsu, China, 213163. | Folic Acid, FCC Grade |
| 33 | Jiangsu Cradlechem Technology Co., Ltd. | No.38 Houyang Chem-Industry Zone, Jintan, Changzhou, China. | 1-chloro-2-methyl-2-propanol |
| 34 | Zhejiang NHU Company Ltd. | No.428 Dadao West Road, Qixing Street, Xinchang County, Zhejiang, China | Vitamin E |
| 35 | Dafeng Hegno Pharmaceuticals Co., Ltd. | South District, Ocean Economy Development Area of Dafeng, Yancheng City, Jiangsu Province, China, 224100. | Vitamin B6 |
| 36 | Changzhou Huaren Chemical Co., Ltd. | 1 Binjiangyi Road, Chunjiang Town, Xinbei District, Changzhou 213127, Jiangsu, China. | (s)-(+)-1,2-Propanediol |
| 37 | Xinxiang Yellow River Fine Chemical Industry Co., Ltd. | Nanguan, Chengguan Town, Yuanyang County, Xinxiang, He’nan 453500, China. | Anhydrous Potassium Fluoride |
| 38 | Genchem & Genpharm (Changzhou) Co., Ltd. | 658 Yulong Road, N., Binjiang Industry Park, Xinbei, Changzhou, Jiangsu, China 213127. | Di – tert – butyl dicarbonate |
| 39 | Suzhou Kaiyuan Minsheng Sci & Tech Co., Ltd.(Contract Manufacturing Name: Siping Fine Chemicals Co., Ltd) | Beishan Lingyuan Road 515, Tiedong Dist, Jilin Province, China 136001 | Racemic Lactam |
| 40 | Zhejiang OMA Pharmaceutical Co., Ltd. | Dazha Road, Jiangkou Industrial Development Zone, Huangyan, Taizhou City, Zhejiang Province, China | 2[(Acetyloxy) methoxy] ethylacetate, CAS#59278-00-1( Pharma intermediate ) |
| 41 | JRS PHARMA GMBH & CO.KG (Microcellulose Weissenborn GmbH+Co.KG） | Weissenborn，Germany | MCC |
| 42 | Merck KGaA (Germany) | Frankfurter Straβe 250, 64293 Darmstadt (Germany) | Mg-Stearate（Sodium Chloride、Meglumine、Sucrose、Calcium Stearate、Talc、sorbitol、Magnesium Oxide、Magnesium Hydroxide Carbonate Heavy Extra Pure、Magnesium Carbonate Basic、 Anhydrous Dibasic Calcium、Sodium acetate thihydrate、Glacial Acetic Acid、Butylated Hydroxytoluene、Di-Sodium hydrogen phosphate anhydrous、Glycerol 85%、Sodium Citrate Dihydrate、stearic acid、fumaric acid、sodium hydroxide、Isopropyl alcohol、Hydrochloric Acid、Benzyl alcoho、Magnesium Stearate、Meglumine、Tryptic Soy Broth Casein-peptone soymeal-peptone broth for microbiology） |
| 43 | Jiangxi Keyuan Biopharm Co., Ltd. | Jishan Industrial Zone, Pengze County, Jiangxi Province, China. | R-Mandelic acid (CAS#611-71-2) |
| 44 | Sundia MediTech Company., Ltd. | No.8 Binhai Road, Liujiagang Town, Taicang City, Jiangsu Province, China | N/A |
| 45 | Zhejiang Jiuzhou Pharmaceutical Co., Ltd. | Waisha Road 99, Jiaojiang, Taizhou, Zhejiang Province, China | N/A |
| 46 | Zhejiang Tianyi Food Additives Co., Ltd. | No.1, New Fulanqiao Road, Wuzhen Town, Tongxiang City, Jiaxing City, Zhejiang Province, China | D-Glucono delta-lactone |
| 47 | Molkerei Meggle Wasserburg GmbH | Wasserburg， Germany | Lactose series pharmaceutical excipients |
| 48 | DFE Pharma (at FrieslandCampina DMV B.V. | Netherland | Pharmatose/ Respitose/Monohydrate Lactose (Excipients) |
| 49 | Evonik | Germany | Acrylic resin |
| 50 | SHANDONG LUYUE CHEMICAL CO., LTD | Anzhan Industrial Park, Feicheng City, Shandong Province, China. | Allyl amine Cls |
| 51 | SHANDONG TONGCHENG MEDICINE CO., LTD. | 9 Jinyuan Road, Project Area, Hou Town, Shouguang City, Shandong, China | 1，3-Dichloropropane |
| 52 | EVONIK | Site Rheinfelden,Untere Kanalstrasse 3,79618 Rheinfelden,Germany | Colloidal Silicon Dioxide |
| 53 | Hetero Labs Limited Unit I | Survey No.10, I.D.A., Gaddapotharam, Jinnaram Mandal, Sangareddy District Telangana, India | Levetiracetam |
| 54 | GE Healthcare | Bjorkgatan 30,SE-75184 Uppsala Sweden | Capto SP ImpRes、Q Sepharose Fast Flow、SP Sepharose Fast Flow |
| 55 | Nouryon | SE445 80 Bohus Sweden | Kromasil 10-100A C8 |
| 56 | GE Healthcare | Bj?rkgatan 30，SE-75184 Uppsala Sweden | Capto SP ImpRes、Q Sepharose Fast Flow、SP Sepharose Fast Flow |
| 57 | JRS | Lohmener Str.12,D-01796 Pirna,Germany | Croscarmellose Sodium |
| 58 | JRS | Frcibcrgcr Str.7,09600 Weissenborn, Germany | microcrystalline cellulose |
| 59 | DFE | Lauenforder Strasse 5，37176 Norten Hardenberg，Germany | Anhydrous Lactose |
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