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www.aurobindo.com |
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Aurobindo receives MCC
South Africa's approval for its Unit XII facility |
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Aurobindo’s facility at unit XII bags yet
another concurrence in MCC (Medicines Control
Council) of South Africa’s endorsement. |
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Medicines Control Council of South Africa in
their resolution following the facility
inspection by their officials has conveyed that
the facility is in compliance with current Good
manufacturing facilities and recommends
registration of products manufactured here with
their authorities in respect to quality. |
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Unit – XII of Aurobindo Pharma Limited is
dedicated to manufacture High-end Betalactum
range of products. The total area is spread over
15,228 Sq. Meters, with a built-up area of
12,180 Sq. Meters. The plant is capable of
manufacturing injectables, powder for oral
suspensions, tablets and capsules. |
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Unit XII is also approved by US FDA, Brazilian
ANVISA; in addition holds ISO and approvals from
several other countries.
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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
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