Key Facts

Innovative Healthcare Solutions – At Amber LifeSciences, we pioneer breakthrough medicines to enhance global well-being. Our dedication to excellence has earned us industry accolades, reinforcing our commitment to advancing healthcare & fostering positive societal change.

Amber Lifesciences CMOs Partners: Global Regulatory Approvals and Research Capabilities

Regulatory Approvals: We work with approved manufacturing partners from leading regulatory bodies across the globe, including the World Health Organization (WHO)

  • USFDA (USA) Approved Manufacturing Partners
  • MHRA (UK) Approved Manufacturing Partners
  • TGA (Australia) Approved Manufacturing Partners
  • Russia (Roszdravnadzor) – Approved Manufacturing Partners
  • HEALTH CANADA (CANADA) Approved Manufacturing Partners
  • ANVISA (Brazil) Approved Manufacturing Partners
  • EMEA (European Union) Approved Manufacturing Partners
  • SFDA (China) Approved Manufacturing Partners
  • MHLW (Japan) Approved Manufacturing Partners
  • SWISSMEDIC (Switzerland) Approved Manufacturing Partners
  • KFDA (Korea) Approved Manufacturing Partners
Ensuring compliance with stringent quality standards. Our extensive network of manufacturing partners spans multiple countries, solidifying our commitment to global accessibility and adherence to regulatory requirements.

Amber Lifesciences collaborates closely with regulatory agencies across Africa, ensuring all products meet stringent standards and approvals. Partnering with trusted manufacturing facilities, we guarantee quality and compliance every step of the way.

  • Benin - Beninese Agency for Pharmaceutical Regulation (ABRP)
  • Burkina Faso - National Agency for Pharmaceutical Regulation of Burkina Faso (ANRP)
  • Burundi - The Burundian Regulatory Authority for Medicines for Human Use and Food (ABREMA)
  • Cameroon - Directorate of Pharmacy and Medicines and Laboratories (DPML)
  • Cape Verde - Entidade Reguladora Independente da Saúde (ERIS)
  • Congo - Directorate of Pharmacy and Medicines
  • Egypt - The Egyptian Drug Authority (EDA)
  • Ghana - Ghana Food And Drugs Authority
  • Ivory Coast - DPML (Direction of Pharmacy, Medicine and Laboratories)
  • Kenya - Pharmacy and Poisons Board (PPB)
  • Malawi - Pharmacy and Medicines Regulatory Authority (PMRA)
  • Mali - Department of Pharmacy and Medicines
  • Mauritania - Directorate of pharmacy and laboratories and processed by the National Medicines Commission (C.N.M)
  • Morocco - Morocco Ministry of Health
  • Namibia - Namibia Medicines Regulatory Council (NMRC),
  • Nigeria - Nigeria National Agency for Food and Drug Administration and Control (NAFDAC)
  • Senegal - Agence sénégalaise de Réglementation pharmaceutique
  • South Africa - SAHPRA
  • Tanzania - Autoridad de Medicamentos y Equipos Médicos (TMDA)
  • Tunisia - DPM, Uganda - National Drug Authority
  • Zimbabwe - Medicines Control Authority of Zimbabwe - MCAZ

Amber Lifesciences forges partnerships with regulatory bodies throughout the Americas and LATAM, securing approvals for our products. We work hand-in-hand with manufacturing partners in the region, ensuring the highest standards of quality and compliance are met.

  • Argentina - ANMAT, Bahamas - Agencia Nacional de Medicamentos,
  • Bolivia - Unidad de Medicamentos y Tecnología en Salud,
  • Chile - Instituto de Salud Pública - ISP,
  • Colombia - Instituto Nacional de Vigilancia de Medicamentos y Alimentos - INVIMA,
  • Costa Rica - Ministerio de Salud,
  • Cuba - Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos - CECMED,
  • Dominican Republic - Dirección General de Drogas y Farmacias - DGDF,
  • Ecuador - Agencia Nacional de Regulación, Control y Vigilancia Sanitaria - ARCSA,
  • El Salvador - Dirección de Medicamentos y Productos Sanitarios,
  • Guatemala - Guatemala Ministry of Public Health and Social Assistance,
  • Guyana - Ministerio de Salud,
  • Honduras - Agencia de Regulación Sanitaria - ARSA,
  • Jamaica - Ministerio de Salud y Bienestar Jamaica,
  • Mexico - Mexico's COFEPRIS,
  • Netherlands Antilles - Departamento de Salud Pública y Protección del Medio Ambiente,
  • Nicaragua - Dirección General de Regulación Sanitaria - Ministerio de Salud,
  • Panama - Dirección Nacional de Farmacia y Drogas,
  • Paraguay - Dirección Nacional de Vigilancia Sanitaria - DINAVISA,
  • Peru - Dirección General de Medicamentos, Insumos y Drogas - DIGEMID,
  • Puerto Rico - SARAFS,
  • Trinidad and Tobago - División de Química, Alimentos y Medicamentos,
  • Uruguay - División Evaluación Sanitaria - Ministerio Salud Pública (MSP),
  • Venezuela - Dirección de Drogas, Medicamentos y Cosméticos

Amber Lifesciences engages in close collaboration with regulatory agencies across Asia, obtaining necessary approvals for our products. Through strategic partnerships with manufacturing facilities in the region, we uphold rigorous standards of quality and compliance, ensuring our products meet the diverse needs of the Asian market.

  • Afghanistan - General Directorate of Pharmaceutical Affairs, Ministry of Public Health (GDPA), Algeria - Algeria Ministry of Pharmaceutical Industry,
  • Armenia - Scientific Centre of Drug and Medical Technology Expertise,
  • Azerbaijan - Center for Analytical Examination,
  • Bahrain - NHRA - National Health Regulatory Authority,
  • Bangladesh - DGDA - Directorate General of Drug Administration,
  • Bhutan - Drug Regulatory Authority,
  • Cambodia - Department of Drugs and Food,
  • China - China’s State Food and Drug Administration (SFDA),
  • Hong Kong - Department of Health,
  • India - India's CDSCO,
  • Indonesia - National Agency of Drug and Food Control,
  • Iran - Iran Food and Drug Administration,
  • Iraq - KIMADIA - State Company for Provision of Medicines and Medical Appliances,
  • Israel - Ministry of Health - Pharmaceutical Division,
  • Japan - Japanese MHLW,
  • Jordan - Jordan Food and Drug Administration (JFDA),
  • Kazakhstan - NDDA - National Center for Expertise of Medicines and Medical Devices,
  • Kuwait - Kuwait Drug and Food Control Administration,
  • Kyrgyzstan - State Department of Medicine Provision and Medical Equipment,
  • Laos - Food and Drug Department,
  • Lebanon - Ministry of Public Health,
  • Malaysia - NPRA - National Pharmaceutical Regulatory Agency,
  • Maldives - Maldives Food and Drug Authority (MFDA),
  • Mongolia - Ministry of Health and Sports,
  • Myanmar - Food and Drug Administration,
  • Nepal - DDA - Department of Drug Administration,
  • Oman - Directorate General of Pharmaceutical Affairs and Drug Control,
  • Pakistan - DRAP - Drug Regulatory Authority of Pakistan (DRAP),
  • Palestine - General Directorate of Pharmacy,
  • Philippines - Food and Drug Administration (FDA),
  • Qatar - Pharmacy and Drug Control,
  • Russia - Federal Service for Surveillance in Healthcare (Roszdravnadzor),
  • Saudi Arabia - Saudi Food and Drug Authority (SFDA),
  • Singapore - Singapore's Health Sciences Authority (HSA),
  • South Korea - Ministry of Food and Drug Safety (MFDS),
  • Sri Lanka - NMRA - National Medicines Regulatory Authority (NMRA),
  • Syria - Directorate of Drug Control,
  • Taiwan - FDA,
  • Thailand - Food and Drug Administration,
  • Turkey - Turkish Medicines and Medical Devices Agency,
  • United Arab Emirates - Ministry of Health and Prevention,
  • Uzbekistan - National Information and Analytical Center on Drugs Control (NCDC),
  • Vietnam - Drug Administration of Vietnam (DAV),
  • Yemen - Supreme Board for Medicine and Medical Appliances.

Amber Lifesciences collaborates closely with regulatory authorities across Europe, securing approvals for our products. Partnering with reputable manufacturing facilities in the region, we uphold strict standards of quality and compliance, ensuring our products meet the stringent regulations of the European market.

  • Albania - Agjencia Kombetare e Barnave dhe Pajisjeve Mjekesore,
  • Austria - Austrian Medicines and Medical Devices Agency,
  • Belarus - MINISTRY OF HEALTH OF THE REPUBLIC OF BELARUS,
  • Belgium - Federal agency for medicines and health products,
  • Brazil - Brazil's (ANVISA),
  • Bulgaria - Bulgarian Drug Agency,
  • Croatia - Agency for Medicinal Products and Medical Devices of Croatia,
  • Cyprus - Pharmaceutical Services - Ministry of Health,
  • Czech Republic - State Institute for Drug Control,
  • Denmark - Danish Medicines Agency,
  • Estonia - State Agency of Medicines,
  • Finland - Finnish Medicines Agency,
  • France - The French National Agency for Medicines and Health Products Safety,
  • Germany - Federal Institute for Drugs and Medical Devices,
  • Greece - National Organization for Medicines,
  • Hungary - National Institute of Pharmacy and Nutrition,
  • Iceland - Icelandic Medicines Agency,
  • Ireland - Health Products Regulatory Authority (HPRA),
  • Italy - Italian Medicines Agency,
  • Latvia - State Agency of Medicines,
  • Liechtenstein - Office of Health / Medicinal Products Control Agency,
  • Lithuania - State Medicines Control Agency,
  • Luxembourg - Ministry of Health,
  • Malta - Medicines Authority,
  • Netherlands - Medicines Evaluation Board,
  • Norway - The Norwegian Medicines Agency,
  • Poland - Chief Pharmaceutical Inspectorate,
  • Portugal - INFARMED – National Authority of Medicines and Health Products,
  • Romania - National Agency for Medicines and Medical Devices of Romania,
  • Slovakia - State Institute for Drug Control,
  • Slovenia - Javna agencija Republike Slovenije za zdravila in medicinske pripomočke,
  • Spain - Spanish Agency of Medicines and Medical Devices,
  • Sweden - Medical Products Agency,
  • Switzerland - Swiss Agency for Therapeutic Products (Swissmedic).

Amber Lifesciences works in tandem with regulatory agencies across Oceania, obtaining approvals for our products. Through partnerships with trusted manufacturing partners in the region, we ensure adherence to high standards of quality and compliance, catering to the needs of Oceania's diverse market.

  • Australia - Australian Therapeutic Goods Administration (TGA),
  • New Zealand - MEDSAFE - Medicines and Medical Devices Safety Authority,
  • Papua New Guinea - Pharmaceutical Services Standards Branch.

Research and Development
At Amber Lifesciences, our partner’s dedicated team of scientists is at the forefront of research and development, continuously striving to innovate and bring forth groundbreaking solutions. We work with clinical research facilities established in numerous countries and advanced R&D centers strategically located worldwide. We facilitate collaboration and knowledge exchange, accelerating the pace of discovery and development in the pharmaceutical industry.
We at Amber lifesciences works with partners for Clinical trial facility with
  • USFDA (USA) Approved Manufacturing Partners
  • USFDA (USA),
  • MHRA (UK),
  • TGA(Australia),
  • CDSCO (India),
  • HEALTH CANADA (CANADA),
  • MCC (South Africa),
  • ANVISA (Brazil),
  • EMEA (European Union),
  • SFDA (China),
  • NAFDAC (Nigeria),
  • MEDSAFE (Newzeland),
  • MHLW (Japan),
  • MCAZ (Zimbabwe),
  • SWISSMEDIC (Switzerland),
  • KFDA (Korea),
  • MoH (Sri Lanka)
and approved World Health Organization (WHO), Pan American Health Organization (PAHO) international regulatory agencies and organizations.
Core Values: Guiding Principles at Amber LifeSciences
At Amber LifeSciences, our core values are the foundation of our commitment to excellence. Integrity, respect, and innovation guide our actions, ensuring that every decision we make prioritizes patient well-being, scientific advancement, and ethical responsibility. These principles drive us to consistently deliver high-quality, impactful healthcare solutions globally.

Accountability

Owning our actions and commitments with personal integrity.

Excellence

Striving for the highest standards in all endeavors, surpassing expectations.

Teamwork

Achieving together through collaboration and synergy.

Integrity

We prioritize ethical conduct and honesty in all our endeavors, ensuring transparency and trustworthiness in every interaction.

Inclusion

Embracing diversity fuels our innovation and fosters a collaborative environment where every voice is valued and respected

Culture and Values At Amber

At Amber, our culture embraces innovation, integrity, and a commitment to excellence.