prequalifying documents - pharmaceutical export...

21
PREQUALIFYING DOCUMENTS

Upload: others

Post on 15-Apr-2020

8 views

Category:

Documents


0 download

TRANSCRIPT

Page 1: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

PREQUALIFYING DOCUMENTS

Page 2: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

April 30, 2014Deputy General Manager – Technical, Lab & ProductionState Pharmaceutical Corporation of Sri LankaNO 75, Sir Baron Jayathilaka Mw,Colombo 01Head OfficePharmexcilPharamaceuticals Export Promotion CouncilHydrabadIndiaDear Sir/Madam,Prequalifying of suppliers – State Pharmaceuticals Corporation of Sri LankaWe are calling applications for prequalification of Pharmaceutical items and MedicalDevices in the attached List.It is appreciated if you can circulate this among pharmaceutical manufacturers in thecountry in order to prequalify their items with State Pharmaceuticals Corporation of SriLanka.Following documents also attached,1. Check list for the prequalification2. Guideline for pre-qualificationThank you,Yours faithfully,

Suranganie PereraDeputy General Manager – Technical, Lab & ProductionState Pharmaceutical Corporation of Sri LankaTel/Fax : 0094-11-2333018Email : [email protected] address : www.spc.lk

Page 3: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

NoticePre-qualification of suppliers of

Pharmaceuticals and Medical DevicesState Pharmaceuticals Corporation of Sri Lanka

In terms of the Guide Lines for procurement of Pharmaceuticals & MedicalDevices approved by the Government, it is necessary that all suppliers of multi-source products to the State Pharmaceuticals Corporation of Sri Lanka (SPC)should be prequalified.

All suppliers of multi-source Pharmaceuticals and Medical Devices who have notfulfilled prequalification are kindly requested to forward their applications afterobtaining documents from State Pharmaceutical Corporation on payment of Rs.1000.00 per item.

Multisource Product list which is applicable for prequalification appeared in theSunday Observer on 27th April 2014.

Please deposit duly filled forms with a copy of the payment receipt of purchasingof forms at the Tender Box on “pre-qualification” at the State PharmaceuticalsCorporation on or before 10.00 am on 03rd July 2014.Tender Ref. No : SPC/14/08/PQ/GEN/03

For further details contact : DGM (Technical, Laboratory & Production)Tel : 2333018

The ChairmanState Pharmaceuticals Corporation of Sri Lanka

75, Sir Baron Jayatilaka MawathaColombo 01

Page 4: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

PHARMACEUTICAL MULTISOURCE PRODUCTS

01. ACARBOSE 50 MG TABLET02. ACECLOFENAC 100 MG TABLET03. ACICLOVIR 200 MG TABLET04. ACICLOVIR 5 % CREAM05. ACICLOVIR OPTHALMIC OINTMENT 3%06. ACICLOVIR 800MG TABLET07. ADAPALENE GEL 0.1 %08. ALBENDAZOLE 400 MG TABLET09. ALENDRONATE SODIUM 10 MG TABLET10. ALENDRONATE SODIUM 70 MG TABLET11. ALFACALCIDOL 0.25 MCG CAPSULE12. ALPRAZOLAM 0.25 MG TABLET13. ALPRAZOLAM 0.5 MG TABLET14. AMIODARONE 200MG TABLET15. AMLODIPINE 10 MG TABLETS16. AMLODIPINE 5 MG TABLETS17. AMOXYCILLIN 125 + CLAVULANIC ACID 31.25 MG / 5 ML SUSPENSION18. AMOXYCILLIN 125 MG SUSPENSION19. AMOXYCILLIN 250 + CLAVULANIC ACID 125 MG TABLET20. AMOXYCILLIN 250 CAPSULE21. AMOXYCILLIN 500 + CLAVULANIC ACID 125 MG TABLET22. AMOXYCILLIN 500 CAPSULE23. AMOXYCILLIN 1000MG + CLAVULANIC ACID 200MG INJECTION (1.2G)24. AMPHOTERICIN B 50 MG INJECTION25. ANASTROZOLE 1 MG TABLET26. ASCORBIC ACID 100 MG TAB27. ASCORBIC ACID 500MG TAB28. ASPIRIN DELAY RELEASED 75 MG TABLET29. ASPIRIN DELAY RELEASED 150MG TABLET30. ATENALOL 100 MG TABLET31. ATENALOL 50 MG TABLET32. ATORVASTATIN 10 MG TAB33. ATORVASTATIN 20 MG TAB34. AZATHIOPRINE 50 MG TABLET35. AZITHROMYCIN 200MG/5ML SUSPENSION36. AZITHROMYCIN 250 MG TAB37. AZITHROMYCIN 500 MG TAB38. BECLOMETHASONE 100 MCG INHALER39. BECLOMETHASONE 400MCG DP CAPSULES40. BENZOYL PEROXIDE 2.5 %, 5% JEL

Page 5: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

41. BETAHISTINE 8MG TABLET 16MG TABLET42. BETAMETHASONE + NEOYOMYCINE CREAM43. BETAMETHASONE CREAM 0.05%44. BETAMETHASONE OINMENT 0.1%45. BISACODYL 5MG TABLET46. BUDESONIDE 200 INHALER47. CALCITRIOL 0.25 MG CAP48. CANDESARTAN 16 MG TAB49. CANDESARTAN 8 MG TAB50. CAPECITABINE 500MG CAPSULE51. CAPTOPRIL 25 MG TAB52. CARBAMAZEPINE 200MG TAB53. CARBIMAZOLE 5MG TABLET54. CARBOPLATIN 10MG/ML55. CARBOPLATIN 450 MG / 45 ML INJECTION56. CARVEDILOL 12.5 MG TAB57. CARVEDILOL 6.25 MG TAB58. CEFALEXIN 250MG CAPSULES59. CEFALEXIN 500MG CAPSULES60. CEFALEXIN ORAL SUSPENSION 125MG/5ML61. CEFEPIME 1G INJECTION62. CEFIXIME 100MG DISPERSIBLE TAB63. CEFIXIME 200 MG TAB64. CEFIXIME ORAL SUSPENSION 100 MG / 5 ML65. CEFOTAXIME 1 G INJECTION66. CEFTAZIDIME 1 G INJECTION67. CEFTRIOXONE 1 G INJECTION68. CEFTRIOXONE 1000MG INJECTION69. CEFUROXIME 125 MG TABLET70. CEFUROXIME 125MG/5ML SUSPENSION71. CEFUROXIME 250 MG TABLET72. CEFUROXIME 500 MG TABLET73. CEFUROXIME 750 MG INJECTION74. CELECOXIB 100 MG CAP75. CELECOXIB 200 MG CAP76. CEPHALAXIN 250 MG CAP77. CEPHALAXIN 500 MG CAP78. CEPHALAXIN SUSPENSION 125 MG / 5 ML79. CEPHRADINE 500 MG CAPSULE80. CETRIZINE 10 MG TABLET81. CETRIZINE 5 MG / 5 ML SYRUP82. CHLORAMPHENICOL EYE / EAR DROP 0.5 %83. CHLORPHENIRAMINE 4 MG TABLET

Page 6: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

84. CHLORPHENIRAMINE SYRUP 2MG/5ML85. CIMETADINE 200 MG TABLET86. CINNARIZINE 25 MG TABLET87. CIPROFLOXACIN 200MG/100ML INFUSION88. CIPROFLOXACIN 250 MG TABLET89. CIPROFLOXACIN 500 MG TABLET90. CIPROFLOXACIN EYE, EAR DROP 0.3 %91. CISPLATIN 10 MG / 10 ML INJECTION92. CISPLATIN 50 MG /50 ML INJECTION93. CITALOPRAM 20MG TABLET94. CLARITHROMYCIN 125 MG / 5 ML SUSPENSION95. CLARITHROMYCIN 250 MG TABLET96. CLARITHROMYCIN 500 MG TABLET97. CLOBETASOL PROPIONATE CREAM 0.05 %98. CLOMIFENE CITRATE 50 MG TABLET99. CLOPIDOGREL 75 MG TABLET100. CLOTRIMAZOLE 1 % CREAM101. CLOTRIMAZOLE 1% BECLOMETHASONE CREAM102. CLOXACILLIN 250 MG CAPSULES103. CLOXACILLIN 500MG CAPSULES104. COMPOUND SODIUM LACTATE INFUSION 500ML105. CO-TRIMOXAZOLE 240 MG / 5 ML SUSPENSION106. CO-TRIMOXAZOLE 480 MG TABLET107. CYCLOSPORIN 100 MG CAPSULE108. CYCLOSPORIN 25 MG CAPSULE109. CYCLOSPORIN 50 MG CAPSULE110. CYPROHEPTADINE 2 MG / 5 ML SYRUP111. DAUNORUBICIN INJECTION 20MG112. DESLORATADINE TABLET 5 MG113. DEXAMETHOSONE 0.5 MG TABLET114. DEXTROMETHORPHAN SYRUP115. DEXTROSE 5 % INJECTION116. DICHLOROBENZYL ALCOHOL 1.2MG LOZENGES117. DICLOFENAC DIETHYLAMMONIUM 1 % GEL TABLET118. DICLOFENAC SODIUM 100 MG SLOW RELEASE TABLET119. DICLOFENAC SODIUM 100 MG SUPPOSITARY120. DICLOFENAC SODIUM 12.5 MG SUPPOSITARY121. DICLOFENAC SODIUM 50 MG TABLET122. DILTIAZEM 90MG TABLET123. DILTIZEM 60 MG TABLET124. DOBUTAMINE 12.5MG INJECTION125. DOCETAXEL INJECTION 120MG/3ML126. DOCETAXEL INJECTION 20 MG / 0.5 ML

Page 7: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

127. DOCETAXEL INJECTION 80MG/2ML128. DOMPEIDONE SYRUP129. DOMPERIDONE 10 MG TAB130. DONEPEZIL 5 MG TAB131. DOXORUBICIN 10 MG INJECTION132. DOXORUBICIN 50 MG INJECTION133. DOXYCYLLINE 100 MG CAP134. DRIED ALUMINIUM HYDROXIDE GEL135. ENALAPRIL 10 MG TAB136. ENALAPRIL 5 MG TAB137. EPIRUBICIN HCL INJECTION 10MG138. ERYTHROMYCIN 250 MG CAP139. ERYTHROMYCIN 500 MG CAP140. ESCITALOPRAM 10MG TABLET141. ESCITALOPRAM 20MG TABLET142. ESCITALOPRAM 5MG TABLET143. ESOMEPRAZOLE 20 MG TAB144. ESOMEPRAZOLE 40 MG TAB145. ESOMEPRAZOLE SODIUM FOR INJECTION 40MG146. ETOPOSIDE 100 MG/5 ML INJECTION147. ETORICOXIB 120MG TABLET148. ETORICOXIB 90MG TABLET149. ETORICOXIB 60MG TABLET150. EZETIMIBE 10MG TABLET151. FAMOTIDINE 20 MG TAB152. FAMOTIDINE 40 MG TAB153. FEROUS SULFATE TABLET 200MG154. FEXOFENADINE 120 MG TAB155. FEXOFENADINE 180 MG TAB156. FEXOFENADINE 60MG TABLET157. FLUCONAZOLE 150 MG CAP158. FLUCONAZOLE 50 MG CAP159. FLUNARAZINE 10 MG CAP/TAB160. FLUNARAZINE 5 MG TAB/CAP161. FLUCINOLONE 0.025% CREAM162. FLUOROMETHOLONE 0.1% EYE DROP163. FLUTICASONE 0.05% NASAL SPRAY164. FLUOROURACIL INJECTION 500 MG/10 ML165. FLUOXETINE 20 MG CAP166. FOLIC ACID 1MG TAB167. FORMETEROL FUMARATE BUDESONIDE 200MCG INHALER168. FORMETEROL BUDESONIDE 400MCG INHALER169. FRUSEMIDE 40 MG TAB

Page 8: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

170. FRUSEMIDE 10MG/ML INJECTION171. FUSIDIC ACID 2% CREAM172. FUSIDIC ACID 2% + HYDROCORTISONE CREAM173. FUSIDIC ACID 2% + BETAMETHASONE CREAM174. GABAPENTIN 100 MG CAP175. GABAPENTIN 300 MG CAP176. GABAPENTIN 400 MG CAP177. GEMCITABINE 1G INJECTION178. GEMCITABINE 2G INJECTION179. GENTAMYCIN 0.3% EYE DROP180. GENTAMYCIN 80 MG/2ML INJECTION181. GLIBENCLAMIDE 5 MG TAB182. GLICLAZIDE 30 MG/MR TAB183. GLICLAZIDE 80 MG TAB184. GLIMIPRIDE 1 MG TAB185. GLIMIPRIDE 2 MG TAB186. GLIMIPRIDE 3 MG TAB187. GLIMIPRIDE 4 MG TAB188. GLIPIZIDE 5 MG TAB189. GLUCASAMINE 750MG TABLET190. GRISEOFULVIN 500 MG TAB191. HYDROCORITISONE 100 MG/ML INJECTION192. HYDROCORTISONE 1% OINMENT193. HYDROCORTSONE 1% CREAM194. HYDROXYCHLOROQUININE 200 MG TAB195. HYOSCINE BUTYL BROMIDE 10 MG TAB196. IBUPROFE N 200 MG TAB197. IBUPROFE N 400 MG TAB198. IBUPROFE N ORAL SUSPENSION199. IMATINIB 100MG CAPSULE/TABLET200. IMIPENAM + CILASTIN 500MG INJECTION201. INDOMETHACIN 25 MG CAP202. ISOSORBIDE MONO NITRATE 20 MG TAB203. ISOSORBIDE MONO NITRATE 60MG SR TABLET204. ITROCONAZOLE 100MG TABLET205. KETOCONAZOLE 2% CREAM206. KETOCONAZOLE 2% SHAMPO207. KETOCONAZOLE 200 MG TAB208. KETOPROFEN 2.5 GEL209. KETOTIFEN 1 MG TAB210. KETOTIFEN SYRUP211. LACTULOSE SYRUP 3.35G/5ML212. LAMOTRIGINE 50 MG TAB

Page 9: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

213. LAMOTRIGINE 100MG TABLET214. LANSOPRAZOLE 30 MG DELAY RELEASE CAPSULE215. LEFLUNOMIDE 10MG TABLET216. LETROZOLE 2.5MG TABLET217. LEVOCETRIZINE DIHYDROCHLORIDE TABLET 5MG218. LEVETIRACETAM 250MG TABLET219. LEVODOPA 250MG + CARBIDOPA 25MG TABLET220. LEVOFLOXACIN 250 MG TAB221. LEVOFLOXACIN 500 MG TAB222. LEVOFLOXACIN 500MG/100ML INFUSION223. LEVONOGESTREL 0.150MG + ETHINYLESTRADIOL 0.030MG224. LEVONOGESTREL 0.75 MG TAB225. LIDOCAINE GEL 2%226. LISINOPRIL 10MG TABLET227. LORATADINE 10 MG TAB228. LORATADINE SYRUP USP 5 MG/5 ML229. LOSARTAN 50 MG USP+HYDROCHLOROTHIAZIDE BP 12.5 MG TAB230. LOSARTAN POTASSIUM 25 MG TAB231. LOSARTAN POTASSIUM 50 MG TAB232. MEBENDAZOLE 100 MG TAB233. MEBENDAZOLE TABLETS USP 500 MG234. MEBEVERINE HYDROCHLORIDE 135 MG235. MEDROXYPROGESTERONE ACETATE INJECTION 150 MG/ML236. MEFENAMIC ACID 250 MG TABLET237. MEFENAMIC ACID TABLETS BP 500 MG238. MEFENAMIC ACID SUSPENSION 100MG/5ML239. MELOXICAM TAB 15 MG240. MELOXICAM TABLETS BP 7.5 MG241. MELPHALAN 2MG TABLET242. MEROPENEM INJECTION 1000 MG243. MEROPENEM INJECTION USP 500 MG244. METFORMIN 500 MG TABLETS245. METFORMIN HYDROCHLORIDE 500 MG EXTE. RELE TABLETS246. METFORMIN HYDROCHLORIDE BP 850 MG TABLETS247. METHOTREXATE 2.5 MG TABLETS248. METHYLDOPA BP 250 MG TAB249. METHYLPREDNISOLONE TABLETS BP 4 MG250. METHYL PREDNISOLONE 16MG TABLET251. METHYLPREDNISOLONE INJECTION 500MG252. METOCLOPRAMIDE 10 MG TABLETS253. METOCLOPRAMIDE 10 MG/2 ML INJECTION254. METRONIDAZOLE 200 MG TABLETS255. METRONIDAZOLE 400 MG TABLETS

Page 10: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

256. METRONIDAZOLE 500 MG/100 ML INJECTION257. MICONAZOLE CREAM 2% CREAM258. MIDAZOLAM 5 MG/ML BP INJECTION259. MIRTAZAPINE 15MG TABLET260. MOMETASONE FUROATE 0.1% USP CREAM261. MOMETASONE FUROATE 0.1% USP OINTMENT262. MONTELUKAST 10 MG TABLETS263. MONTELUKAST 4 MG TABLETS264. MONTELUKAST 5 MG TABLETS265. MOXIFLOXACIN 0.5% OPTHALMIC SOLUTION266. MOXIFLOXACIN 400MG TABLET267. MUPIROCIN OINTMENT USP 2%268. MYCOPHENTOLATE MOFETIL 500 MG CAP/TAB269. MYCOPHENTOLATE MOFETIL 250MG CAPSULE/TABLET270. NABUMETONE 500MG TABLET271. NAPROXEN 500MG TABLET272. NEBIVOLOL 5MG TABLET273. NIFEDIPINE S.R 20MG TAB274. NORETHESTERONE BP 5MG TAB275. NORFLOXACIN 400MG TAB276. OFLOXACIN 200MG TAB277. OFLOXACIN 200MG/100ML INJECTION278. OFLOXACIN 400MG TAB279. OFLOXACIN OPTHALMIC SOLUTION USP 0.3% EYE DROP280. OLANZAPINE 10MG TAB281. OLANZAPINE 5MG TAB282. OLMESARTAN MEDOXOMIL 20MG TABLET283. OLOPATADINE 0.1% OPTHALMIC SOLUTION284. OMEPRAZOLE 20 MG CAP285. OMEPRAZOLE 40MG INJECTION286. ONDANSETRON 4MG TABLET287. ONDANSETRON 2MG/ML INJECTION288. ORLISTAT 120MG CAPSULE289. OXALIPLATIN 100MG/50ML INJECTIONS290. OXALIPLATIN 50MG INJECTION 50MG/10ML291. OXYMETAZOLINE HYDROCHLORIDE 0.05% NASAL SOLUTION292. OXYMETAZOLINE HYDROCHLORIDE 0.025% NASAL SOLUTION293. OXYTOCIN INJECTION BP 5IU/ML294. PACLITAXEL FOR INJECTION 100MG/16.67ML295. PACLITAXEL FOR INJECTION 260MG/43.47ML

Page 11: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

296. PACLITAXEL FOR INJECTION 30MG/5ML297. PANTOPRAZOLE 20MG TAB298. PANTOPRAZOLE 40MG TAB299. PANTOPRAZOLE FOR IV INJECTION 40MG300. PARACETAMOL (PAEDIATRIC) SYRUP 120MG/5ML301. PARACETAMOL 500MG TAB302. PAROXETINE 20MG TABLET303. PERMETHRIN 0.5% SOLUTION304. PIOGLITAZONE 15MG TAB305. PIOGLITAZONE 30MG TAB306. PIPERACILLIN + TAZOBACTUM INJECTION 4.5G307. PIROXICAM 20MG CAP308. POVIDONE IODINE OINTMENT 5%309. POVIDONE IODINE TOPICAL SOLUTION 10%310. POVIDONE IODINE TOPICAL 7.5% CLEANSING SOLUTION311. PRASUGREL 10MG TABLET312. PRAZOSIN 1MG TAB313. PREDNISOLONE 5MG TAB314. PREDNISOLONE ACETATE 1% OPTHALMIC SUSPENSION315. PREGABALIN 75MG CAP316. PREGABLIN 150MG CAP317. PREGABALIN 100MG CAPSULE318. PROPOFOL INJECTION 1%319. QUETIAPINE FUMARATE 100MG TAB/320. RABEPRAZOLE 10MG TAB321. RABEPRAZOLE 20MG TAB322. RAMIPRIL 2.5MG CAP/TAB323. RAMIPRIL 5MG CAP/TAB324. RANITIDINE 150MG TAB325. RANITIDINE BP 25MG/ML INJECTION326. RISPERIDONE 1MG TAB327. RISPERIDONE 2MG TAB328. ROSUVASTATIN CALCIUM 10MG TAB329. ROSUVASTATIN CALCIUM 20MG TAB330. ROSUVASTATIN CALCIUM 5MG TAB331. ROXITHROMYCIN 150MG TAB332. SALBUTAMOL 2MG TAB

Page 12: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

333. SALBUTAMOL 4MG TAB334. SALBUTAMOL ORAL SOLUTION 2MG/5ML335. SALBUTAMOL PRESSURISED INHALATION 100MCG336. SALMETEROL 25MCG + FLUTICASONE PROPIONATE 125MCG METER DOSE

INHALATION337. SALMETEROL 25MCG +FLUTICASONE PROPIONATE 250MCG MDI INHALATION338. SALMETEROL 50MCG + FLUTICASONE 250MCG DRY POWDER CAPSULE339. SALMETEROL 50MCG + FLUTICASONE PROPIONATE 500MCG DRY POWDER CAPSULE340. SERTRALINE 100MG TAB341. SERTRALINE 50MCG TAB342. SILDENAFIL CITRATE 100MG TAB343. SILDENAFIL CITRATE 50MG TAB344. SILVER SULPHADIAZINE 1% W/W CREAM345. SIMVASTATIN 10MG TAB346. SIMVASTATIN 20MG TAB347. SITAGLIPTIN 50MG TABLET348. SITAGLIPTIN 100MG TABLET349. SODIUM CHLORIDE INJECTION BP 0.9% INFUSION350. SODIUM FUSIDATE OINTMENT 2%351. SODIUM VALPROATE 200MG TAB352. SPIRANOLACTONE 25MG TAB353. SULFASALAZINE 500MG TABLET354. TACROLIMUS 1MG CAPSULE355. TACROLIMUS 0.03%356. TADALAFIL 10MG TAB357. TADALAFIL 20MG TAB358. TAMOXIFEN CITRATE 10MG TAB359. TAMSULOSIN 0.4MG CAP360. TELMISARTAN 20MG TABLET361. TELMISARTAN 40MG TABLET362. TELMISARTAN 40MG & HYDROCHLOROTHIAZIDE 12.5MG TABLET363. TELMISARTAN 80MG TABLET364. TEMOZOLAMIDE 250MG CAP365. TEMOZOLOMIDE 100MG CAP366. TERBENAFINE HCL 1% CREAM367. TERBUTALINE 2.5MG TABLET368. TIMOLOL MALEATE 0.5% EYE DROP

Page 13: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

369. TOPIRAMATE 100MG TAB370. TOPIRAMATE 25MG TAB371. TOPIRAMATE 50MG TAB372. TRAMADOL 50MG CAP373. TRAMADOL HCL 50MG/ML INJ INJECTION374. TRANEXAMIC ACID 500MG CAP375. TRANEXAMIC ACID INJECTION 500MG/5ML376. VALSARTEN 80MG TAB377. VANCOMYCIN 500MG INJECTION378. VERCURONIUM BROMIDE 10MG INJECTION379. VENLAFLEXINE 37.5MG CAP380. VINCRISTINE SULPHATE 1MG INJECTION381. VITAMIN B COMPLEX SYRUP382. VITAMIN B COMPLEX TABLET383. VITAMIN E 200MG CAP384. VITAMIN E 400MG CAP385. WATER FOR INJECTION B.P386. ZOLEDRONIC ACID 4MG INJECTION

Page 14: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

MEDICAL DEVICES MULTISOURCE LIST 2014

1 ABSORBENT COTTON WOOL2 ABSORBENT GAUZE ROLL (BP/BPC/USP/SLS)3 ARTERIAL SEPTAL DEFECT OCCLUDER4 BLOOD GLUCOSE SENSOR ELECTRODES/STRIPS/FOR MONITORING5 BLOOD GLUCOSE MONITORING SYSTEM WITH STANDARDS COMPOUND6 BIOPSY INSTRUMENT SET [GUN SYSTEM/NEEDLE/NEEDLE FOR BIOPSY

GUN/BIOPSY FORCEPS]7 CERVICAL COLLOR SOFT/HARD (SPONDYLOSIS)8 CLOSED WOUND SUCTION DRAINAGE SYSTEM9 COLOSTOMY BAG [CLOSED / OPEN SYSTEM]

10 CONDOM MALE, LATEX CONTRACEPTIVE11 CORONARY EXPANDABLE BALLOON DILATION CATHETER FOR

ANGIOPLASTY (PTCA)12 CRAPE BANDAGE COTTON - ELASTIC (BP/USP)13 CRAPE BANDAGE ELASTIC - NON ADHESIVE (BP/BPC/USP)14 DIALYZER (HOLLOW FIBER BLOOD PURIFICATION SET)15 ECG / EEG GEL / CREAM (SKIN PREPERATION)16 ECG RECORDING PAPER17 ECG ELECTRODES18 ENDOTRACHEAL TUBE WITH CUFF / WITHOUT CUFF19 EXTENSION TUBE / (SET FOR INFUSION / TRANSFUSION / PERFUSION SET)20 FACE MASK - DISPOSABLE NON WOVEN (SURGEON/NUSER)21 FEEDING TUBE - INFANT22 FITSULA NEEDLE SET FOR HAEMODIALYSIS ARTERIAL & VENOUS23 FOLEY BALLOON CATHETER 2 - WAY24 GLASS IONOMER CEMENT / RESTORATIVE MATERAL25 GLOVES - LATEX EXAMINATION26 GLOVES - SURGICAL LATEX STERILE27 GUIDE WIRE - PTCA / PTA28 GUIDING CATHETER - PTCA/CLOT EXTRACTION CATHETER

Page 15: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

29 HYPODERMIC NEEDLE30 I/V CANNULA WITH / WITHOUT INJECTION PORT31 INTRAUTERINE CONTRACEPTIVE DEVICE COPPER - T WITH/WITHOUT

INSERTION TUBE (IUCD)32 INTRAVENOUS ADMINSTRATION SET (NON VOLUMETRIC) (SOLUTION

ADMINISTRATION SET /INFUSION SET /GIVING SET)

33 INTRAVENOUS ADMINSTRATION SET WITH MEASURED VOLUME METER& WINGS(I/V SET / GIVING SET)

34 INTRADUCER SHEATH SET/CATHETER INTRODUCER SHEATH SET35 LANCETS S/S FOR BLOOD SAMPLING36 LARYNGEAL MASK AIR WAY WITH / WITHOUT SOFT SEAL CUFF37 LIGATING CLIP38 MALE CONDOM CATHETER EXTENSION - SELF SEALING39 MICRO SCISSORS40 NASAL CANNUALA41 NASAL OXYGEN CANNULA WITH / WITHOUT TUBING42 NEEDLE FOR SPINAL EPIDURAL ANAESTHESIA43 OXYGEN REGULATOR WITH FLOW METERS AND HUMIDIFIER FOR

MEDICAL USE44 OXYGEN MASK FOR ANAESTHESIA45 OXYGEN MASK WITH/WITHOUT TUBING SET46 OXYGENATOR ADULT WITH ACCESSORIES HOLLOW FIBER MEMBRAINE47 OXYGENATOR PAEDIATRIC WITH ACCESSORIES HOLLOW FIBER

MEMBRAINE48 PARAFFIN GAUZE DRANINGS49 PENCIL POINT SPINAL NEEDLE WITH/WITHOUT INTRODUCER FOR

SPINAL ANAESTHESIA50 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON

DILATION CATHETER(FOR FEMORAL , ILLIAC & RENAL ARTERIES

51 PERIPHERAL/TRANS HEPATIC BILLIARY STENT DELIVERY SYSTEM52 PLASTER OF PARIS BANDAGE (P.O.P BANDAGE BP/USP)53 PRESSURE MONITORING KIT & ACCESSORIES54 PRESSURE MONITORING LINE55 RESUSCITATORS - MANUAL BREATHING SYSTEM (AMBUBAG)56 RETRACTOR57 SCALP VEIN SET58 SKIN STAPLER & LOADING UNIT

Page 16: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

59 SUCTION CATHETER60 SUCTION TUBE/SUCTION SET YANKAUER61 SURGICAL BLADE STAINLESS STEEL62 SURGICAL DRAPES/INCISE DRAPES63 SYRINGES WITH/WITHOUT NEEDLE 10ML64 SYRINGES WITH/WITHOUT NEEDLE 1ML65 SYRINGES WITH/WITHOUT NEEDLE 20ML66 SYRINGES WITH/WITHOUT NEEDLE 3ML67 SYRINGES WITH/WITHOUT NEEDLE 50ML68 SYRINGES WITH/WITHOUT NEEDLE 5ML69 SUTURE - BRAIDED COATED ABSORBABLE SUTURE70 SUTURE - BRAIDED COATED NON ABSORBABLE SUTURE71 SUTURE - MONOFILAMENT ABSORBABLE SURGICAL SUTURE72 SUTURE - MONOFILAMENT NON ABSORBABLE SUTURE73 SUTURE - MONOFILAMENT POLYAMIDE NEEDLE SUTURE74 SUTURE - MONOFILAMENT POLYDIOXANONE VIOLET NEEDLE SUTURE75 SUTURE - NYLON / POLYAMIDE MONOFILAMENT NEEDLE

SUTURE/USP/BP SUTURE76 SUTURE - POLY DIAXANONE MONOFILAMENT NEEDLE SUTURE77 SUTURE - POLYESTER COATED BRAIDED MONOFILAMENT NEEDLE

SURGICAL SUTURE78 SUTURE - POLYGLYCOLIC ACID COATED BRAIDED NEEDLE SUTURE79 SUTURE - POLYGLYCOLIC ACID UNCOATED BRAIDED NEEDLE SUTURE80 SUTURE - POLYPROPYLENE MONOFILAMENT NEEDLE SUTURE81 SUTURE - SILK BLACK BRAIDED & COATED NEEDLE SUTURE USP/BP82 3WAY STOP COCKS83 TRACHEOSTOMY TUBE84 UMBILICAL CORD CLAMP85 URINE COLLECTION BAG86 VAGINAL SPECULUM87 WOW BANDAGE88 ZINC OXIDE ADHESIVE SURGICAL PLASTER/TAPE/BANDAG BP USP

Page 17: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

Guideline for pre-qualification

All information provided should be relevant to the specific procurement

COMPANY PROFILE

1. Name of Firm (Manufacturer):………………………………………………………………………………………………………

2. Name of Local Agent:……………………………………………………………………………………………………………………

3. Street Address/Postal code/City/Country:…………………………………………………………………………………….

4. Po.box mailing Address:………………………………………………………………………………………………………………..

5. Tel No:………………………………………………………………………………………………………………………………………….

6. Fax No:………………………………………………………………………………………………………………………………………….

7. E-mail Address:……………………………………………………………………………………………………………………………..

8. Web Address:……………………………………………………………………………………………………………………………….

9. Contact Name:………………………………………………………………………………………………………………………………

10. Contact Title:………………………………………………………………………………………………………………………………..

11. Parent Company if any (full Legal Name):……………………………………………………………………………………..

12. Subsidiaries Associates/Overseas Representatives if any:…………………………………………………………….

Page 18: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

13. Nationality of the Firm:………………………………………………………………………………………………………………..

14. Type of Business:………………………………………………………………………………………………………………………….

15. Nature of Business:……………………………………………………………………………………………………………………….

16. Year Established:………………………………………………………………………………………………………………………

17. Back ground of the Top management:………………………………………………………………………………………….

Professional qualifications Number of Years of

Experience

i. Management

ii. Production

iii. QA/QC

iv. R&D

PRODUCT INFORMATION

18. Pre qualifying Item with the standard:….………………………………………………………………………………………

19. Dosage form:………………………………………………………………………………………………………………………………..

20. Strength/Volume:…………………………………………………………………………………………………………………………

21. Specification of the Product:………………………………………………………………………………………………..……….

22. Analytical Reports of finished product from WHO accredited Laboratory:......………………………….…..

Page 19: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

23. WHO/GMP certificate (Recommendations of country of manufactured):……………………………………..

24. COPP certificate / Free sale certificate of Prequalifying Item:……………………………………………………….

25. Analytical reports of Raw materials:……………………………………………………………………………………………..

26. Real time stability data for two batches:……………………………………………………………………………………….

27. Name of Active Pharmaceutical Ingredient’s Manufacturer:…………………………………………………………

28. Selection Criteria of API Manufacturer:…………………………………………………………………………………………

29. International Standard followed by the Manufacturer:…………………………………………………………………

30. WHO Prequalification Status for the product:……………………………………………………………………………….

EVIDENCE

31. Registration certificate of the Product in the country of manufactured:…..…………………………………..

32. Certificate of Registration in Sri Lanka (CDDA) certified by the Lawyer:…..……………………………………

33. List of countries that are currently using the Product.(If it is used please mark it(√))

country country country

i Australia v Malaysia ix Thailand,

ii Canada vi Singapore x European Union Countries

iii USA vii Switzerland xi

iv Japan viii Sweden xii

34. Evidence using above Country/Countries

i. Registration certificate:…………………………………………………………………………………………………..

ii. COPP Certificate :……………………………………………………………………………………………………

COMMERCIAL DATA

35. Annual average turnover (quantity of particular product):……………………………………………………………

Page 20: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

36. Current contract details: (If available):…………………………………………………………………………………………

37. Annual Audited financial reports of last 3 yrs 1..…………………………………………………………………………..

2..…………………………………………………………………………..

3…………………………………………………………………………….

Above details are true and accurate.

Date:……………………………… ……………………………...…………………………..

Signature of the Manufacturer/Supplier

Page 21: PREQUALIFYING DOCUMENTS - Pharmaceutical Export …pharmexcil.com/uploads/files/SPCSPREQUALIFYINGDOCUMENTS.pdf · PREQUALIFYING DOCUMENTS. April 30, 2014 Deputy General Manager –

Check List for the Prequalification

1. Manufacturer / Supplier Company Profile

i. Name, address & contact details of manufacturer/supplierii. Manufacturing experience ( no. of years), company historyiii. GMP certificateiv. International standards of the plant – surgical

2. Product Information

i. Analytical report of finished productii. Analytical report of active pharmaceutical ingredientsiii. Stability dataiv. Annual turnover for the productv. COPP certificate – pharmaceuticals/free sale certificate for medicaldevicesvi. CDDA Certificate (certified copy)

3. Legal Agent’s Informationi. Name, address & contact details

4. Letter of Authorization for suppliers when representing the manufacturer

5. Financial information for 03 years

i. Cash flow statementii. Balance sheet

iii. Profit & loss accountiv. Independent Auditors’ reports

All documents should be certified as true copies by the Sri Lankan Embassyin the country