Regulatory

Our unwavering commitment to regulatory compliance at Alkaloids Bioactives ensures that our products meet the highest international standards. By adhering to stringent guidelines and proactively engaging with regulatory bodies worldwide, we demonstrate our dedication to excellence, quality and customer trust.

Global
Approvals & Certifications

We have successfully passed inspections and secured approvals from renowned global regulatory bodies, ensuring the highest quality and safety for our products.

Certifications & Accreditations:

  • US FDA, ANSM, TGA, NMPA, CDSCO
  • GMP Certifications & Written Confirmations
  • ISO 9001 & ISO 22000
  • AYUSH and HALAL Certifications
  • Kosher Certification

Customer Assurance: Regular successful customer audits further highlight our commitment to excellence.

Comprehensive
Drug Master File (DMF) Submissions

Our dedication to transparency and compliance is reflected in the submission of numerous Drug Master Files (DMFs) to leading regulatory agencies, including:

  • US FDA, TGA, MHRA, ANSM, CBGMEB, ANVISA, NMPA
  • INFARMED, TFDA, AIFA, Medsafe, BfArM
  • DMA, AEMPS, MPA, EOF, TMMDA, MFDS, and more.
Ongoing Collaboration with Regulatory Authorities

We maintain open channels of communication with global regulatory bodies to stay updated on evolving standards and ensure continuous compliance. Our proactive approach reinforces our reputation as a trusted partner in the pharmaceutical, nutraceutical, and cosmeceutical industries.

Commitment to Quality & Compliance

Through rigorous adherence to global regulatory requirements, Alkaloids Bioactives ensures its products are safe, reliable, and meet the expectations of customers worldwide. Our focus on compliance is a testament to our mission to deliver quality without compromise.

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Transforming Healthcare, Together.

Join hands with Alkaloids Bioactives to create innovative, sustainable solutions in healthcare and wellness. Let’s shape a healthier world together—start your journey with us today!

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Herb Extraction Capacity
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At Alkaloids Bioactives Pvt Ltd, we are pioneers in manufacturing plant-derived Active Pharmaceutical Ingredients (APIs), Nutraceuticals and Cosmeceuticals.
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Plant Address

834(P) Medchal Shamirpet Road, Medchal Mandal, Medchal-Malkajgiri District, Hyderabad, Telangana, India, 501401

Registered Office

8 Bentinck Street, Kolkata, India, 700001

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