Active Pharmaceutical Ingredients

Active Pharmaceutical Ingredients (APIs) are the fundamental components of any medication responsible for its intended therapeutic effect. Often referred to as the “active substance” or “bulk drug,” the API is the biologically active molecule within a final pharmaceutical formulation (like a tablet, capsule, injection, or cream) that interacts with the body to diagnose, treat, cure, mitigate, or prevent disease. The remaining ingredients in the formulation, known as excipients, serve various functions like stabilization, delivery, flavoring, or bulking, but lack the core pharmacological activity. The purity, quality, consistency, and safety of APIs are paramount, as they directly impact the efficacy and safety of the final drug product. Rigorous manufacturing standards, stringent quality control (QC), and adherence to regulatory guidelines (such as cGMP – current Good Manufacturing Practice) are essential throughout API production. Suppliers like Alfa Chemistry play a vital role in providing high-quality API chemical to the pharmaceutical industry globally.   Spotlight on Key API Chemicals Protamine Sulfate (CAS 9009-65-8): Protamine sulfate is a highly basic, low molecular weight protein derived from fish sperm. Its primary therapeutic application lies in its ability to act as a heparin antagonist. Heparin, a potent anticoagulant used during surgeries and dialysis, prevents blood clotting. Protamine sulfate binds ionically to heparin, forming a stable complex that neutralizes heparin’s anticoagulant effect. This reversal is critical in situations where excessive bleeding due to heparin needs to be rapidly controlled post-procedure or in cases of heparin overdose.   Benzhexol Hydrochloride (CAS 52-49-3): Also known as trihexyphenidyl hydrochloride, benzhexol hydrochloride is an anticholinergic agent primarily used in the management of Parkinson’s disease and drug-induced extrapyramidal symptoms. It works by blocking muscarinic acetylcholine receptors in the central nervous system. This helps restore the balance between dopamine and acetylcholine, alleviating symptoms like tremors, rigidity, and bradykinesia associated with Parkinsonism. It can also help control sialorrhea (excessive drooling).   Glycine (CAS 56-40-6): Glycine, the simplest amino acid, serves diverse functions within the pharmaceutical and nutraceutical industries. As an API, it finds application in intravenous solutions for total parenteral nutrition (TPN), acting as a source of nitrogen and helping to maintain protein synthesis. It’s also used as an irrigation solution during transurethral prostatectomy (TURP) procedures due to its non-conductive properties. Beyond direct therapeutic use, glycine is a crucial building block for synthesizing more complex peptides and proteins, and it acts as a buffering agent and stabilizer in various injectable formulations.   Promestriene (CAS 39219-28-8): Promestriene is a synthetic estrogen specifically designed for topical application. It is primarily indicated for the local treatment of symptoms arising from estrogen deficiency in the urogenital tract, particularly postmenopausal atrophic vaginitis. Unlike systemic estrogens, promestriene exerts its effects locally on the vaginal epithelium with minimal systemic absorption, helping to restore vaginal tissue health, improve lubrication, and relieve symptoms like dryness, itching, and dyspareunia (painful intercourse) with a reduced risk of systemic side effects.   Epalrestat (CAS 82159-09-9): Epalrestat is an aldose reductase inhibitor used specifically for the treatment of diabetic neuropathy, retinopathy, and nephropathy—complications arising from chronically elevated blood sugar levels. It works by inhibiting the enzyme aldose reductase, which is part of the polyol pathway responsible for converting excess glucose into sorbitol in nerve, eye, and kidney tissues. Accumulation of sorbitol is believed to contribute to tissue damage. By inhibiting this pathway, Epalrestat aims to prevent or slow the progression of these debilitating diabetic complications.   Alfa Chemistry: Your Trusted API Supplier   Alfa Chemistry has established itself as a prominent global supplier of high-purity active pharmaceutical ingredients, catering to the demanding needs of the pharmaceutical, biotechnology, and research sectors. The company offers an extensive portfolio of APIs, including specialized compounds like protamine sulfate, benzhexol hydrochloride, glycine (CAS 56-40-6), promestriene, and epalrestat. Alfa Chemistry distinguishes itself through its commitment to stringent quality control protocols that meet or exceed industry standards, including cGMP where applicable. Their offerings typically feature high chemical purity, precise documentation (including Certificates of Analysis), and reliable batch-to-batch consistency, which are critical for pharmaceutical development and manufacturing. Beyond providing the raw materials, Alfa Chemistry supports its clients with detailed technical information, regulatory support documentation, and responsive customer service. By ensuring a dependable supply chain of diverse and critical APIs, Alfa Chemistry empowers researchers and manufacturers to innovate and deliver safe and effective medicines to patients worldwide.

Proregulations

Proregulations is an experienced regulatory consulting firm. By creating a 24-hour global network of consulting services and a team of technical experts, we provide high-quality regulatory and scientific consulting services for companies in the industrial chemicals, food and food contact materials, pesticides, cosmetics, medical device and pharmaceutical industries. We have extensive experience and understanding of the knowledge and skills required to address a wide range of regulatory issues. 

Protheragen-ING

Protheragen-ING is engaged in the introduction of various chemical products to the global market, including active pharmaceutical ingredients (APIs), pharmaceutical excipients, veterinary chemicals, membrane materials, packaging materials. We are also a solution provider for chemistry-related analysis services.

CD Formulation

CD Formulation is a leading manufacturer of excipients, serving the pharmaceutical industry to help it improve the performance of its products. We develop, produce and sell pharmaceutical excipients for solid, semi-solid and liquid dosage forms. Our excipients include: binders, colorants, diluents, disintegrants, emulsifiers, lubricants, plasticizers, surfactants, fillers and so on. In addition, we can provide preformulation, formulation, analytical, solubility improvement and bioavailability enhancement, packaging and custom pharmaceutical excipients services to address the needs and formulation challenges of our customers.

Alfa Chemistry

Alfa Chemistry, a global Contract Research Organization (CRO) specializing in organic chemistry, material chemistry, and medicinal chemistry, is ISO 9001:2015 certified. Alfa Chemistry provides building blocks, research chemicals, reagents, catalysts, and reference materials. We also offer custom synthesis, and analytical services.

Alfa Chemistry

Alfa Chemistry, a global Contract Research Organization (CRO) specializing in organic chemistry, material chemistry, and medicinal chemistry, is ISO 9001:2015 certified. Alfa Chemistry provides building blocks, research chemicals, reagents, catalysts, and reference materials. We also offer custom synthesis, and analytical services.

Creative Biolabs

Recombinant antibody technology defines the future of biopharmaceutical development, Creative Biolabs says A prominent CRO, Creative Biolabs, has announced their intention to drive the biopharmaceuticals industry forward and has highlighted the role of recombinant antibody engineering in research and drug development efforts. Creative Biolabs is transforming the scope of biopharmaceutical development with its cutting-edge recombinant antibody products and custom antibody discovery solutions. Their specialized products, like antibodies, antibody-like scaffold proteins, and antibody-cytokine fusion proteins, apply to both pharmaceutical discovery projects and disease research endeavors. “Our flagship product, recombinant antibodies, offers high-affinity solutions for a wide variety of applications, from therapeutic development to diagnostic assays, almost covering any prevalent research target. Our robust recombinant DNA technology platform for antibody production and versatile expression systems ensure the highest purity and specificity in the yielding antibodies, enabling researchers to achieve accurate and reliable results.” According to a scientist at Creative Biolabs. Creative Biolabs also supplies the most comprehensive list of antibody-like scaffold proteins, including over 30 different types, such as 10-FnIII, Min-23, ubiquitin, Kunitz domains, PDZ domain, and Z-domain of protein A, which possess the ability to simultaneously interact and/or bind with multiple other proteins and organize partner proteins into a framework to facilitate their concerted interactions and functions. Those scaffold proteins provide a stable framework for the design of novel biologics and can be customized to meet specific research needs. Moreover, Creative Biolabs excels in the development of functional immunocytokines, especially antibody-cytokine fusion proteins (ACFP), a groundbreaking approach to enhancing the efficacy and specificity of immunotherapeutic agents. By combining the targeting capabilities of antibodies with the immune-modulating properties of cytokines, the fusion proteins hold promise for the treatment of cancer, autoimmune diseases, and other conditions. “Our fusion proteins have distinctive advantages, including a rather low immunogenicity, a high affinity of subnanomolars, and outstanding solubility in aqueous solutions.” The scientist introduced. “At Creative Biolabs, we are dedicated to pushing the boundaries of biopharmaceutical development through our innovative antibody solutions. Our commitment to excellence and scientific advancement drives us to deliver premium products and services that empower our clients to make a difference in the field of biotechnology. Our antibody and protein products that I’ve just highlighted are just the tip of the iceberg.” Website: https://www.creativebiolabs.net/ AboutUtilizing advanced techniques like recombinant DNA, Creative Biolabs is able to rapidly customize antibodies for various applications, covering both diagnostics and therapeutics. A group of scientists will attend several 2024 industry conferences to share views with global researchers about frontier discoveries and establish partnerships. Their agenda includes BIO International 2024, World Bispecific Summit, Exosome-Based Therapeutic Summit, and World ADC San Diego.  

Prof. Joshua Yindenaba Abor, PhD, FCCA, FGA

Joshua Yindenaba Abor is a financial economist, qualified accountant. Professor of Finance and former Dean, University of Ghana Business School. He is an Adjunct Professor of Development Finance at the University of Stellenbosch Business School as well as an Adjunct Professor of Finance at SDD-University of Economic Research Consortium. He is an External Fellow at the Centre for Global Finance, SOAS University of London and a Fellow of the Ghana Academy of Arts and Sciences. He has held Visiting Scholar positions at the International Monetary Fund (IMF), Washington DC, US. He also serves on the boards of some companies, including SAS Finance Group, and chairs the SIC Life Company Ltd board. (The Largest life insurance company in Ghana) and is currently a member of the Bank of Ghana Monetary Policy Committee.

Dr. Elikplimi K. Agbloyor

Dr. Elikplimi K. Agbloyor is a Consultant at the Corporate Support Group Ltd and a Senior Lecturer at the University of Ghana Business School. He is also a research fellow in the Faculty of Economic and Management Sciences, University of Stellenbosch Business School, South Africa. He spent a year’s Sabbatical in Australia and was part of the Teaching Team for International Finance at the Monash Business School (a G8 University in Australia and ranked in the Top 100 globally). He is a financial economist, chartered accountant, and risk management, expert. He has several years of teaching, research, and consulting experience. Elikplimi has also consulted for organizations including the International Finance Corporation (IFC), Ghana Oil and Gas for Inclusive Growth (GOGIG), and the National Banking College. He is a researcher with the African Economic and Research Consortium (AERC). Elikplimi has facilitated training programs in retirement planning for a number of institutions including SSNIT, WAEC, and the Ghana Ports and Harbour Authority (GPHA). Elikplimi has experience in managing investment portfolios and has traded CFDs, commodities, derivatives, ETFs, and stocks.