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Facilities |
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As a part of a major expansion plan of our existing Paracetamol facility, this new facility was established in early 2006. The facility is a dedicated plant for the manufacture of Paracetamol with an annual capacity of 12000MT/annum. This facility will have all necessary global approvals by early next year. This facility meets all regulated requirements required by the US FDA, Australian TGA and German Health Authority. |
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Granules India Limited
Temple road, Bonthapalli
Jinnaram Mandal,
Mandak Distict - 501 313
Tel: +91 8458 275362
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Established in 1994, this facility has been built as a multi-product facility. At this facility several APIs and PFIs have been commercialized over the last few years. This site meets the latest WHO cGMP standards and has been inspected by US FDA, Australian TGA & German HA. Our superior product quality has helped us establish supply chains with major pharma giant across the globe. |
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Granules India Limited
Plot No. 15/A/1, Phase III,
I.D.A. Jeedimetla,
Hyderabad - 500 055
Tel: 91 40 23098462, 23096942
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Established in 2003, the Gagillapur facility is World's single largest multi-product granulation plant with a capability of 6 MT per batch and 7200 MT per annum.
This ultra modern granulation facility is a dedicated, advanced and an automated plant. The facility has been audited and approved by the FDA, Australian TGA and German regulatory body. Some of the key features of the facility are: |
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We control quality through a prudent backward integration into selective and strategic API manufacture. |
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The facility is equipped with two granulation suites and SWECO sifters in both suites possess built-in metal detectors and 16,000 liter octagonal blenders, which can deliver batches of six tonnes each. |
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Sophisticated state-of-the-art laboratory comprising top-of-the-line analytical equipment like HPLCs, GCs, FTIRS, UV-VIS spectrophotometer, TOC analyser, particle size analysers and a microbiological laboratory, ensuring a compliance with various pharmacopoeial requirements. |
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Complete operational automation (SCADA /PLC-based). |
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Well-designed HVAC system with a class 10,000 atmosphere wherever required. |
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Decontamination booth for incoming material. |
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Laminar flow booth for the sampling of raw material. |
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Raw material warehouse provided with 5 micron filtered air. |
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Automated dispensing system for APIs. |
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Laminar flow booth for dispensing excipients. |
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Granules India Limited
Plot No. 160/A & 161/E,
Gagillapur Village,
Qutubullapur Mandal,
RR District - 500 043
Tel: 91 8418 255233, 257222, 257121
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R & D at Granules is a service organization which is catering to our in-house product development requirements for both PFI and Finished dosage. Our in-house development philosophy is to corroborate and offer a business model of delivering end to end solutions for OTC -monograph, which is required for filing ANDA.
We have a highly experienced team with a global experience. Our focus is on immediate and sustained-release dosage forms. We possess ability to develop several products and file ANDAs/Dossiers in the USA, Europe, Australia and many other countries.
Our R&D focus is to create a business offering which compresses a set of documents that can serve as a document template for all regulated markets such as US, Canada, Europe and Australia.
Being a company whose business model evolved around PFIs, we have developed compression and in-vitro tests.
The infrastructure is also designed to cater to the requirements of our customer on a contract basis. Consequently our customers are leveraging on our intellectual capability and state of the art manufacturing facilities.
We are well supported by a scale up and production facilities and class 100,000 R & D facility, which meets the global standards. The facility is spread over 3500 Sq.ft. with an expansion plan of up to 7000 Sq. ft. by mid 2007 |
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