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Stringent Quality control & Quality assurance system as per GMP ICH Q7 guidelines |
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Technical documentation support for regulatory filings. |
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Analytical Instruments like HPLC's, GC's, GC with headspace for residual solvent analysis. |
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Muffle Furnace, Polarimeter, Potentiometric titrator, UV Spectrophotometer & IR |
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Melting Point Apparatus, Karl Fischer, TLC chamber, Vacuum oven. |
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Stability Chambers for stability studies. |
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Unit I is approved by U.S. Food and Drug Administration. |
