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Drug Approvals in South Africa

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01 4Genzyme Biopharmaceuticals SA (Pty) Ltd

02 366Sanofi Aventis South Africa (Pty) Ltd

03 33Winthrop Pharmaceuticals (Pty) Ltd

04 63AbbVie (Pty) Ltd

05 1Abbvie (Pty) Ltd

06 4Allergan Pharmaceuticals (Pty) Ltd

07 1355Pharmacare Limited, Woodmead

08 150Dr Reddy's Laboratories (Pty) Ltd

09 75Strides Pharma SA (Pty) Ltd

10 1Strides S.A. Pharmaceuticals (Pty) Ltd

11 63M South Africa (Pty) Ltd

12 9AHN Pharma (Pty) Limited

13 8APOTHECON LABS cc

14 97Abbott Laboratories SA (Pty) Ltd

15 46Abex Pharmaceutica (Pty) Ltd

16 184Accord Healthcare (Pty) Ltd

17 145Acino Pharma (Pty) Ltd

18 10Actavis Pharma (Pty) Ltd

19 64Activo Health (Pty) Ltd

20 52Actor Pharma (Pty) Ltd

21 1Actor Pharma (Pty) Ltd.

22 1138Adcock Ingram Critical Care (Pty) Ltd

23 6Adcock Ingram Healthcare (Pty) Ltd

24 1411Adcock Ingram Limited

25 2Adven Pharma (Pty) Ltd

26 77Akacia Health Care (Pty) Ltd

27 22Alcon Laboratories (Sa) (Pty) Ltd

28 22Alliance Pharma (Pty) Ltd

29 93Alliance Pharmaceuticals

30 13Allied Drug Company

31 27Amgen South Africa (Pty) Ltd

32 3Ando Pharma (Pty) Ltd

33 1Applicant Name as Registered with MCCSAHPRA

34 53Arrow Pharma South Africa (Pty) Ltd

35 45Arya Pharma (Pty) Ltd

36 72Ascend Laboratories (Pty) Ltd

37 7Ascendis Pharma (Pty) Ltd

38 25Astellas Pharma (Pty) Ltd

39 3AstraZeneca Pharmaceuticals (Pty) Ltd

40 25Astral Pharma (Pty) Ltd

41 9Astrazeneca Pharmaceuticals (Pty) Ltd

42 3Astrazeneca Pharmaceuticals (Pty) Ltd - Bryanston

43 98Astrazeneca Pharmaceuticals (Pty) Ltd - Sunninghill

44 32Astrazeneca Pharmaceuticals (Pty) Ltd- Bryanston

45 2Astrazeneca Pharmaceuticals (Pty) Ltd- Sunninghill

46 47Aurobindo Pharma (Pty) Ltd

47 136Aurogen South Africa (Pty) Ltd

48 156Austell Laboratories (Pty) Ltd

49 5Austell Pharmaceuticals (Pty) Ltd

50 161Austell Pharmaceuticals (Pty) Ltd

51 55Axim Pharmaceuticals (Pty) Ltd

52 741B. Braun Medical (Pty) Ltd

53 1BEIGENE SOUTH AFRICA (PTY) LTD

54 91Baroque Pharmaceuticals (Pty) Ltd

55 4Barrs Pharmaceutical Industries (Pty) Ltd

56 10Baxter HealthCare South Africa (Pty) Ltd

57 74Baxter Healthcare South Africa (Pty) Ltd

58 191Bayer (Pty) Ltd

59 63Be Tabs Pharmaceuticals (Pty) Ltd

60 4Bennetts The Chemists (Pty) Ltd

61 225Biotech Laboratories (Pty) Ltd

62 3Bliss Pharmaceuticals

63 55Bodene (Pty) Ltd

64 153Boston Scientific (Pty) Ltd

65 6Brimpharm SA (Pty) Ltd

66 5Brimpharm Sa (Pty) Ltd

67 73Bristol-Myers Squibb (Pty) Ltd

68 12Brunel Laboratoria (Pty) Ltd

69 27Camox Pharmaceuticals (Pty) Ltd

70 33Caps Pharmaceuticals

71 1Cipla Life Sciences (Pty) Ltd

72 643Cipla Medpro (Pty) Ltd

73 6Cipla Medpro Manufacturing (Pty) Ltd

74 5Concord Food & Drug Distributors CC

75 4Cospharm Investment (PTY) LTD

76 3Curanto Pharma (Pty) Ltd

77 6Delfran (Pty) Ltd

78 51Dezzo Trading 392 (Pty) Limited T/A Indo Pharma

79 23Dezzo Trading 392 (Pty) Ltd

80 2Eco Pharmaceuticals (Pty) Ltd

81 11Eisai Pharmaceuticals Africa (Pty) Ltd

82 71Eli Lilly (SA) (Pty) Ltd

83 1Elttab Pharmaceuticals

84 37Emcure Pharmaceuticals South Africa (Pty) Ltd

85 7Encha Health (Pty) Ltd

86 101Equity Pharmaceuticals (Pty) Ltd

87 67Eurolab (Pty) Ltd

88 27F.D.C. SA (PTY) LTD

89 2F.D.C. SA (Pty) Ltd

90 41Ferring (Pty) Ltd

91 89Forrester Pharma (Pty) Ltd

92 133Fresenius Kabi Manufacturing SA (Pty) Ltd

93 1051Fresenius Kabi SA (Pty) Ltd

94 1337Fresenius Kabi South Africa (Pty) Ltd

95 37Fresenius Medical Care SA (Pty) Ltd

96 21GE Healthcare (Pty) Ltd

97 17Galderma Laboratories South Africa (Pty) Ltd

98 14Gen-Eye (Pty) Ltd

99 16Gen-Eye (pty) Ltd

100 7Genop Healthcare (Pty) Ltd

101 5Gilead Sciences South Africa (Pty) Ltd

102 2GlaxoSmithKline Consumer Healthcare (Pty) Ltd

103 40GlaxoSmithKline Consumer Healthcare South Africa (Pty) Ltd

104 226GlaxoSmithKline South Africa (Pty) Limited

105 2GlaxoSmithKline South Africa Pty Ltd

106 121Glaxosmithkline South Africa (Pty) Ltd - Cape Town

107 53Glenmark Pharmaceuticals South Africa (Pty) Ltd

108 2Goldex 775 (Pty) Ltd

109 63Guerbet South Africa (Pty) Ltd

110 127Gulf Drug Company (Pty) Ltd

111 30H. Lundbeck (Pty) Ltd

112 1Haleon S. A. (Pty) Ltd 

113 7Henry Schein Dental Warehouse (Pty) Ltd

114 161Hetero Drugs South Africa (Pty) Ltd

115 1IPM South Africa NPC

116 7Imperial Market Access Healthcare SA (Pty) Ltd

117 152Ingelheim Pharmaceuticals (Pty) Ltd

118 1Ingwe Lifescience (Pty) Ltd

119 118Innovata Pharmaceuticals (Pty) Ltd

120 198Janssen Pharmaceutica (Pty) Ltd

121 198Johnson & Johnson (Pty) Ltd

122 36Jubilant Pharma SA (Pty) Ltd

123 6Juno Pharma SA (Pty) Ltd

124 19Kahma Biotech (Pty) Ltd

125 40Key Oncologics (Pty) Ltd

126 52Kiara Health (PTY) LTD

127 27LHC Pharmaceuticals (Pty) Ltd

128 4Lamar International (Pty) Ltd

129 10LeBasi Pharmaceuticals (Pty) Ltd

130 47LeBasi Pharmaceuticals CC

131 4Lebasi Pharmaceuticals (Pty) Ltd

132 15Lebasi Pharmaceuticals CC

133 68Litha Pharma (Pty) Ltd

134 2Litha Vaccines

135 2Loock Pharmaceuticals (Pty) Ltd

136 19MC Pharma (Pty) Ltd

137 3MDI HEALTHCARE CC

138 146MSD (Pty) Ltd

139 285Macleods Pharmaceuticals SA (Pty) Ltd

140 28Mallinckrodt (Pty) Ltd

141 8Meda Pharma South Africa (Pty) Ltd

142 3Medchem Pharmaceuticals

143 7Medi Challenge

144 77Medicine Developers International CC

145 15Medicine Developers International Healthcare cc

146 17Medivision (Pty) Ltd

147 3Medpro Pharmaceutica (Pty) Ltd

148 1Medwich Pharma (Pty) Ltd

149 4Mentholatum South Africa (Pty) Ltd

150 123Merck (Pty) Ltd

151 1MeyerZall Laboratories (Pty) Ltd

152 18Micro Healthcare

153 2Mirren (Pty) Ltd

154 42Mundipharma (Pty) Ltd

155 191Mylan (Pty) Ltd

156 79NTP Radioisotopes (Pty) Ltd

157 21National Bioproducts Institute (NPC)

158 6Norgine (Pty) Ltd

159 65Novagen Pharma (Pty) Ltd

160 327Novartis South Africa (Pty) Ltd

161 64Novo Nordisk (Pty) Ltd

162 6ORTHOMEDICS PHARMACEUTICALS (PTY) LTD

163 24Octapharma SA (Pty) Ltd

164 1Oethmaan Biosims

165 98Oethmaan Biosims (Pty) Ltd

166 2Omnimed

167 17Opella Healthcare South Africa (Pty) Ltd

168 3Opus Pharmaceuticals (Pty) Limited

169 1Orchid Pharmaceuticals SA (Pty) Ltd

170 114Organon South Africa (Pty) Ltd

171 273Pfizer Laboratories (Pty) Ltd

172 352Pharma Dynamics (Pty) Ltd

173 49Pharma Q (Pty) Ltd

174 48Pharma-Q Holdings (Pty) Ltd

175 9Pharmaceutical Contractors (Pty) Ltd

176 44Pharmaceutical Enterprises (Pty) Ltd

177 27Pharmachemie (Pty) Ltd

178 2Pharmacia South Africa (Pty) Ltd

179 66Pharmaco Distribution (Pty) Ltd

180 44Pharmacorp (Pty) Ltd

181 7Pharmafrica (Pty) Ltd

182 15Pharmaplan (Pty) Ltd

183 12Pharmascript Pharmaceuticals Ltd

184 6Phyto OTC Health (Pty) Ltd

185 6Pierre Fabre South Africa (Pty) Ltd

186 7Piramal Critical Care South Africa (Pty) Ltd

187 2Portfolio Laboratories (Pty) Ltd

188 22Procter & Gamble SA (Pty) Ltd

189 4RX Medicals (Pty) Ltd

190 469Ranbaxy Pharmaceuticals (Pty) Ltd

191 89Ranbaxy S.A (Pty) Ltd

192 35Reckitt Benckiser Pharmaceuticals (Pty) Ltd

193 5Resmed Healthcare

194 1Roche Products (Pty) Ltd

195 146Roche Products (Pty) Ltd

196 15Ruby Pharmaceuticals (Pty) Ltd

197 2SCP Pharmaceuticals (Pty) Ltd

198 10SMART PHARMACEUTICALS (PTY) LTD

199 34Safeline Pharmaceuticals (Pty) Ltd

200 610Sandoz SA (Pty) Ltd

201 71Sandoz SA Pty Ltd

202 22Schering-Plough (Pty) Ltd - (Site1)

203 24Sekpharma (Pty) Ltd

204 126Servier Laboratories S.A. (Pty) Ltd

205 4Shanur Healthcare (Pty) Ltd

206 8Smith & Nephew Pharmaceuticals (Pty) Limited

207 30Soflens (Pty) Ltd

208 8Sonke Pharmaceuticals (Pty) Ltd

209 6South African Vaccine producers (PTY) LTD

210 3Spear Pharmaceuticals

211 75Specpharm (Pty) Ltd

212 2Specpharm Holdings (Pty) Ltd

213 2Sun Pharmaceuticals SA (Pty) Ltd

214 45Takeda (Pty) Ltd

215 5Technikon Laboratories (Pty) Ltd

216 6Tema Medical (Pty) Ltd

217 217Teva Pharmaceuticals (Pty) Ltd

218 5The Biovac Institute

219 57Thebe Medicare

220 16Thebe Medicare (Pty) Ltd

221 201Trinity Pharma (Pty) Ltd

222 12Umsebe Healthcare

223 57Unichem SA (Pty) Ltd

224 139Unicorn Pharmaceuticals (Pty) Ltd

225 77Unimed Healthcare (Pty) Ltd

226 145Viatris Healthcare (Pty) Ltd

227 89Viatris South Africa (Pty) Ltd

228 14Watson Pharma No. 1 (Pty) Ltd

229 22Western Province Blood Transfusion Service

230 5Wyeth Consumer Healthcare

231 108Xixia Pharmaceuticals (Pty) Ltd

232 29Zentiva South Africa (Pty) Ltd-Midrand

233 4Zimbili Pharma CC

234 209Zydus Healthcare SA (Pty) Ltd

235 98iNova Pharmaceuticals (Pty) Ltd

236 13iPharma (Pty) Ltd

237 18iThemba LABS

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PharmaCompass

01

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Articaine hydrochloride

Brand Name : Ubistesin Forte

Dosage Form : INJ

Dosage Strength : 40mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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02

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Articaine hydrochloride

Brand Name : Ubistesin

Dosage Form : INJ

Dosage Strength : 40mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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03

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Lidocaine hydrochloride

Brand Name : Xylestesin-A

Dosage Form : INJ

Dosage Strength : 20mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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04

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Adrenaline

Brand Name : Ubistesin Forte

Dosage Form : INJ

Dosage Strength : 0.01mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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05

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Adrenaline

Brand Name : Ubistesin

Dosage Form : INJ

Dosage Strength : 0.01mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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06

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Adrenaline

Brand Name : Xylestesin-A

Dosage Form : INJ

Dosage Strength : 0.012mg/ml

Packaging : 50X1mg/ml

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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07

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Rosuvastatin

Brand Name : Lypstaplus 10 mg/10 mg

Dosage Form : Tab

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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08

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Rosuvastatin

Brand Name : Lypstaplus 20 mg/10 mg

Dosage Form : Tab

Dosage Strength : 20mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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09

COMPAMED
Not Confirmed
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COMPAMED
Not Confirmed

Ezetimibe

Brand Name : Lypstaplus 20 mg/10 mg

Dosage Form : Tab

Dosage Strength : 10mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Generic

Registration Country : South Africa

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10

Applicant Name as Registered with MCCSAH...

Country
COMPAMED
Not Confirmed
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Applicant Name as Registered with MCCSAH...

Country
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COMPAMED
Not Confirmed

Active Ingredients

Brand Name : Medicine Proprietary Name

Dosage Form : Dosage Form

Dosage Strength : StrengthUnit

Packaging : Pack SizeXQuantityUnit

Approval Date :

Application Number :

Regulatory Info : Originator or Generic

Registration Country : South Africa

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