Who Are We?
SanKav Pharmaceuticals provides the global community with small molecule, organic treatments and medicines. Through innovative state-of-the-art personalized medicines, we seek to cure and prevent common and rare diseases for diverse individuals in rural and urban communities.
OUR MISSION
We exist to provide holistic solutions for disease prevention and control through natural medicine and integrative health technologies.
OUR VISION
We envision a world where children, adults, and the elderly are healthy and have access to proper nutrition, medical services, treatments, and education regardless of their backgrounds, financial circumstances, and
geographical locations.
OUR TEAM
SanKav Pharmaceuticals was founded and is led by Dr. Sanjeev K. Gupta. It has now grown to a diverse team of highly trained professionals, from scientists and operators to engineers and quality managers. Together, we have 200+ years of pharmaceutical industry experience and resources:
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State of the art and modern facilities with automated and advanced technologies
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Expert in regulatory documentation
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Manage electronic data systems
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Focused and timely project management
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Experienced in serving virtual company & company with facilities
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Flexible to meet your needs
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Continuous quality improvement is our mantra
What are our industries?
Pharmaceuticals
Pharmaceutical products are approved by FDA for patient or consumer use. A pharmaceutical drug (also referred to as medication and drug) is a drug used to diagnose, cure, treat, or prevent disease. Drugs are classified by the level of control, which distinguishes prescription drugs from over-the-counter drugs (those that consumers can order for themselves). Another key distinction is between traditional small-molecule drugs, usually derived from chemical synthesis, and biopharmaceuticals, which include recombinant proteins, vaccines, blood products used therapeutically, gene therapy, monoclonal antibodies and cell therapy (for instance, stem-cell therapies).
Definition of Biologics: Biologics can be derived from animal and plant sources. “Biology is a branch of science that deals with living organisms and their vital processes. Biology encompasses diverse fields, including botany, conservation, ecology, evolution, genetics, marine biology, medicine, microbiology, molecular biology, physiology, and zoology.”
Pharmaceutical is Synthetic Drug: small molecules, peptides, other complex drugs, etc. (File to FDA as NDA - New Drug Application)
Biological is Natural Drug: Antibodies, Cells, Genes, Proteins, Polysaccharides, Fatty acids, Amino Acids, Peptides, etc and combinations thereof. Also may be combined with small molecule drug conjugates example, ADC (antibody drug conjugate). (File to FDA as BLA - Biologics License Application)
Regulatory Definitions:
Over-The-Counter (OTC): FDA approved monographs of Non-prescription drugs
Brand Drugs: Pre-clinical, Pre-Investigational New Drug Application, Pre-IND, Investigational New Drug Application, IND and New Drug Application, NDA [505(b)(1) or NDA 505(b)(2)]
Generic Drugs: Abbreviated New Drug Application, a 505(b)(j) under FDA Guidances
Biologic Drugs: Biologics License Application, BLA 351(a)
Biosimilar Drugs: Under the Biologics Price Competition and Innovation Act (BPCI Act), a biological product may be demonstrated to be “biosimilar” if data show that, among other things, the product is “highly similar” to an already-approved biological product. Filed as a Therapeutic Biologics Application, 351(k); Analytical, animal and clinical studies to prove similarity to an approved biologic product.
Nutraceuticals
Nutraceutical products are derived from food sources. They are medical food products formulated to be consumed or administered internally. Nutraceuticals include non-specific biological therapies used to promote general well-being, control symptoms and prevent malignant processes. Its plays an important role in a plethora of biological processes, including antioxidant defenses, cell proliferation, gene expression, and safeguarding of mitochondrial integrity. Nutraceuticals have attracted considerable interest due to their potential nutritional, safety and therapeutic effects
Categories: dietary supplements, functional food, medicinal food, farmaceuticals
Drug Delivery Platforms
Drug delivery refers to approaches, formulations, technologies, and systems for transporting a pharmaceutical compound in the body as needed to safely achieve its desired therapeutic effect. Drug delivery technologies modify drug release profile, absorption, distribution and elimination for the benefit of improving product efficacy and safety, as well as patient convenience and compliance. SanKav will be researching and developing new, more efficient drug delivery platforms.