3V Sigma USA: A Certified Pharmaceutical Chemical Manufacturer with In-House Testing Services
The pharmaceutical industry is a sector of the healthcare industry that is focused on the discovery, development, production, and marketing of medications and drugs for the treatment of various medical conditions and diseases. The industry includes companies that research and develop new drugs, as well as those that manufacture and distribute medications.
3V SIGMA USA offers several ingredients that can be used in OTC drugs as well as excipients in drug products. Applications include controlled-release tablets, bio-adhesion (buccal, ophthalmic, intestinal, nasal, vaginal and rectal applications), highly stable oral suspensions (where they can stabilize insoluble ingredients) or highly stable oil-in-water emulsions using low amounts of irritating surfactants.
The Synthalen® P line is a line of rheology modifiers specifically designed and manufactured for the pharmaceutical industry. Very low concentrations (less than 1%) of these rheology modifiers produce a wide range of viscosities and flow properties in topical lotions, creams and gels, oral suspensions, and in transdermal gel reservoirs.
Synthalen® P grade can guarantee Safety & Effectiveness as they are non-sensitizing, cannot penetrate the skin thanks to their extremely high molecular weight, and have no effect on the biological activity of the drug while providing an excellent vehicle for drug delivery. They are easy to utilize and the obtained formulations are also stable to repeated freezing/thawing cycles as well as autoclaving.
Safety and regulations are of paramount importance in this industry. 3V SIGMA USA is certified under ISO9001:2015, EFfCI, and is following IPEC guidelines for cGMP manufacturing. Our commitment to quality goes even further for our excipients line where we deposited a voluntary type IV DMF to FDA providing an easier path for our customers to create their own DMF for drug products when using these excipient-grade ingredients.
Our certified Quality Control and Quality Assurance departments follow strict SOPs allowing all the required testing to be performed in-house on every lot, which allows 3V SIGMA USA to guarantee purity, quality, and ultimately safe usage.
Finally, Synthalen® P grade polymers comply with many of the world’s pharmacopeia guidelines, enabling our customers to enjoy the ease of sale of formulations worldwide.
We are a global chemical manufacturing company specializing in the formulation and production of a wide range of chemical products for various industries. Through innovation, rigorous testing and attention to quality, 3V Sigma USA contributes high-performing chemicals to the worlds largest global industries.