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SUBMIT × Close THANK YOU FOR YOUR INTEREST. PLEASE ENTER YOUR DETAILS We use cookies to ensure that we give you the best experience on our website. Ok HPAPI TALK TO AN EXPERT Home Manufacturing HPAPI RELATED OFFERINGS API Manufacturing KNOW MORE Finished Dosage Manufacturing KNOW MORE Lifecycle Management KNOW MORE HPAPI A global leader with over five decades of experience, our FDA approved cGMP state-of-the-art facility of Piramal Pharma Solutions located in Riverview, MI (USA) offers High Potency API (HPAPI) services, and a full range of scale and containment options. × Close THANK YOU FOR YOUR INTEREST. PLEASE ENTER YOUR DETAILS Select Primary Interest Area Discovery Services API Services Formulation Services Antibody Drug Conjugate Generics APIs Nutrition Solutions Job Applications Others Select Country* Afghanistan Aland Islands Albania Algeria Andorra Angola Anguilla Antarctica Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Berlin Bermuda Bhutan Bolivia, Plurinational State of Bonaire, Sint Eustatius and Saba Bosnia and Herzegovina Botswana Bouvet Island Brazil British Indian Ocean Territory Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Chinese Taipei Christmas Island Cocos (Keeling) Islands Colombia Comoros Congo Congo, the Democratic Republic of the Cook Islands Costa Rica Cote d'Ivoire Croatia Cuba Curaçao Cyprus Czech Republic Denmark Deutschland Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Falkland Islands (Malvinas) Faroe Islands Fiji Finland France French Guiana French Polynesia French Southern Territories Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guatemala Guernsey Guinea Guinea-Bissau Guyana Haiti Heard Island and McDonald Islands Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran, Islamic Republic of Iraq Ireland Isle of Man Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Kuwait Kyrgyzstan Lao People's Democratic Republic Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macao Macedonia Madagascar Malawi Malaysia Maldives Mali Malta Martinique Mauritania Mauritius Mayotte Mexico Moldova, Republic of Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nauru Nepal Netherlands New Caledonia New Zealand Nicaragua Niger Nigeria Niue Norfolk Island North Korea Norway Oman Pakistan Palestine Panama Papua New Guinea Paraguay Peru Philippines Pitcairn Poland Portugal Principauté de Monaco Puerto Rico Qatar Reunion Romania Russian Federation Rwanda Saint Barthélemy Saint Helena Saint Kitts and Nevis Saint Lucia Saint Martin (French part) Saint Pierre and Miquelon Saint Vincent and the Grenadines Samoa San Marino Sao Tome and Principe Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Sint Maarten (Dutch part) Slovakia Slovenia Solomon Islands Somalia South Africa South Georgia and the South Sandwich Islands South Korea South Sudan Spain Special Administrative Region Sri Lanka Stockholm Sudan Suriname Svalbard and Jan Mayen Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania, United Republic of Thailand Timor-Leste Togo Tokelau Tonga Trinidad and Tobago Tunisia Turkey Turkmenistan Turks and Caicos Islands Tuvalu Uganda Ukraine United Arab Emirates United Kingdom United States Uruguay Uzbekistan Vanuatu Venezuela, Bolivarian Republic of Viet Nam Virgin Islands, British Wallis and Futuna West Africa Western Sahara Yemen Zambia Zimbabwe Please keep me informed of products, services and offerings from Piramal Pharma Solutions By Email I accept Piramal's Privacy Policy. SUBMIT Specialized Capabilities Up to 4,000 L Glass Lined Reaction Vessels with a Temperature Range of -70°C to 200°C Product Isolation Capabilities: Extraction, Filtration, Centrifugation, and Distillation Drying/finishing facility: Scaled Rosenmund Filter Dryers with Glovebox Technology, Forced Air & Vacuum Drying Ovens, and Class 10,000 Clean Suites Track record of successful launches, robust engineering controls and a stellar safety record make us a preferred 'Partner of Choice' for high potency projects High potent API manufacturing suites with airlocks and barrier isolation systems (OELs ≥ 20ng/m3 at Kilo-lab scale) Services Offered Development and manufacture of commercial High Potent API compounds Process Research, Development, Optimization and Scale-Up cGMP Manufacturing for Clinical Trials Comprehensive analytical and regulatory services to support early-stage development Impurity Identification, Characterization, and Synthesis Solid-State Characterization (XRPD, DSC, TGA and PSD) Quality by Design (QbD) Services Consistent with ICH Guidelines Process Safety Team – Project and Scale-up Safety Assessments Safety/Hazard identification and risk assessments Hazard Assessment Laboratory Instrumentation: RC-1, DSC, TSU, ARC Documentation for Regulatory Submissions (IND, NDA, DMF, CTD) Salient features 15 US FDA Manufacturing Approvals (NCEs) Significant experience in fast track approvals and orphan diseases Successful global regulatory inspection history: US FDA, EU (QPs), Health Canada, PMDA Japan, MFDS Korea, TGA Australia, COFEPRIS Mexico, and Russia among others A longstanding provider of contract research services to the National Institutes of Health (NIH) and the National Cancer Institute (NCI) High Potency API Needs Piramal Pharma Solutions now offers High Potency API (HPAPI) services following its acquisition of Ash Stevens, a leader in HPAPI development and c... 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