DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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Drug Registration Guidance Document (DRGD)NO.SUBSTANCES72. HYDROQUINONE73. IMMUNOSUPPRESANTS74. INSULIN75. INGREDIENTS DERIVED FROM SEAFOOD76. KAOLIN, PECTIN, KAOLIN-PECTIN77. KETOCONAZOLE78. KETOROLAC TROMETHAMOL (KETOROLAC TROMETHAMINE)79. LEVODOPA80. LINCOMYCIN81. LISURIDE82. LIQUID PARAFFIN83. LOPERAMIDE84. LORATADINE85. LORAZEPAM86. METHYL SALICYLATE87. METHYLPHENIDATE HCL88. METOCLOPRAMIDE89. MICONAZOLE90. MIDAZOLAM91. MINOXIDIL92. MUCOLYTIC AGENT93. NEVIRAPINE94. NIFEDIPINE95. NITRATES96. NITRAZEPAMNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 356
Drug Registration Guidance Document (DRGD)NO.SUBSTANCES97. NORFLOXACIN98. NORMAL GLOBULIN99. NOSCAPINE100. NONSTEROIDAL ANTI-INFLAMMATORY DRUG (NSAID)101. OLANZAPINE102. PARACETAMOL103. PARACETAMOL WITH CAFFEINE IN COMBINATION104. PELARGONIUM SIDOIDES105. PENICILLIN106. PHENIRAMINE107. PHENYLEPHRINE108. PIRIBEDIL109. PIROXICAM110. PRAMIPEXOLE111. PROMETHAZINE HCL112. PROPAFENONE113. PROPOFOL114. PROPOLIS (TOPICAL)115. PROPYLTHIOURACIL116. PSEUDOEPHEDRINE117. PSYCHOTROPIC PRODUCTS118. QUETIAPINE119. QUINAGOLIDE120. RISPERIDONE121. ROPIRINOLENational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 357
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PART III: NON-CLINICAL DATADrug Reg
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- All information must be provided
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1.2 EXEMPTION FROM PRODUCT REGISTRA
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For product containing Red Yeast Ri
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Page 306 and 307: Drug Registration Guidance Document
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DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

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