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www.aurobindo.com |
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MCC South Africa approves 4
Products |
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Aurobindo Pharma South Africa, a
wholly owned subsidiary of Aurobindo Pharma Ltd,
India is proud to announce the approval for four
of its ARVs from
the Medicines Control Council (MCC) of South
Africa. |
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South Africa is a very important and highly
regulated market. Approvals from MCC for these
ARVs augurs the beginning of Aurobindo’s journey
in South African pharmaceutical formulations
space. |
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Approved products: |
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Lamivudine
Tablets 150 mg |
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Zidovudine
Tablets 300 mg |
Nevirapine Tablets 200 mg
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Lamivudine 150
+Zidovudine Tablets 300 mg. |
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Aurobindo is vertically integrated in all these
products and manufactures both API and
formulations. |
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While Lamivudine, Zidovudine belong to class of
NRTI, Nevirapine belongs to NNRTI Class of Anti
retroviral drugs meant for the treatment of
HIV-1 infection. Lamivudine, Zidovudine and
Nevirapine are very popular in the management of
HIV infection. |
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About Aurobindo Pharma Limited: |
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Aurobindo Pharma Limited (www.aurobindo.com),
headquartered at Hyderabad, India, manufactures
generic pharmaceuticals and active
pharmaceutical ingredients. The company’s robust
product portfolio is spread over 6 major
therapeutic/product areas encompassing
(Antibiotics, Anti-Retrovirals, CVS/ Statins/Diabetology,
CNS, Gastro/Uro/Kidney therapeutics, Anti
fungal/ allergics/respiratory) around 65
Betalactam APIs and 123 Non-Betalactam APIs.
The Company markets its products
in over 100 countries. The company has filed
over 65 ANDAs and 88 DMFs for the USA market, in
addition to several filings in other countries.
The company has received approvals for several
facilities from leading regulatory agencies like
US FDA, UK MHRA, WHO, Health Canada, MCC South
Africa. |
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Unit
Certifications |
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Unit |
Certifications |
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API |
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Unit I |
US FDA |
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Unit 1 A |
US FDA |
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Unit VI A |
Health Canada, US FDA
(pre approval over) |
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Unit VIII |
US FDA, WHO |
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Unit XI |
US FDA |
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Formulations |
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Unit III |
US FDA, UK MHRA,
WHO, Health Canada, MCC (SA), Brazil Anvisa
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Unit VI B |
US FDA, MCC (SA), Health
Canada, Brazil Anvisa |
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Unit XII |
US FDA, Health
Canada, UK MHRA, Brazil Anvisa
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For further information,
please contact:
Investor Relations
Aurobindo Pharma Limited
Plot # 2, Maitri Vihar | Ameerpet
Hyderabad - 500 038 |India
Phone (Board): +91 40 5572 5000
Email : ir@aurobindo.com |
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PRESS
ROOM
