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www.aurobindo.com |
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US FDA successfully completed
Aurobindo's unit XI (Vizag) Inspection |
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Aurobindo Pharma is
pleased to announce that the US FDA has
successfully inspected and rated Unit XI, one of
the API manufacturing facilities, as
“Acceptable” (complying with all cGMP
requirements). |
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Aurobindo is also
delighted to share that the inspection has been
successful without any 483s. |
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The facility is
spread over 110 acres of land and consists of
eleven production blocks. It is one of the
prestigious and biggest manufacturing facility
of Aurobindo Pharma Limited. Apart from US FDA
approval, this facility also holds local FDA,
WHO GMP Certificate (Drug Control Admn. A. P.,
India) and ISO 9001—2000 certification. |
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Unit XI is located
at Vizag, Andhra Pradesh, India (port city of
Andhra Pradesh). |
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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. |
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The Company markets
its products in over 100 countries. The company
has filed over 50 ANDAs and 69 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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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: |
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Karthik Krishnan
Aurobindo Pharma Limited
Plot # 2, Maitri Vihar, Ameerpet
Hyderabad - 500 038 India
Phone (Board): +91 40 5572 5000
karthik.krishnan@aurobindo.com |
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