Axcentria is a full service Contract Manufacturing Organization. That means we can be your “virtual” partner for product development, procurement, manufacturing, product testing, warehousing, inventory management and customer fulfillment. This gives you the freedom to focus on what’s most important: the marketing and sales of your products.
Frequently Asked Questions
General Industry & Certification
There are big differences. FDA pharmaceutical regulations are the highest standards for any of the above categories. Pharmaceutical standards require manufacturers like Axcentria to follow current Good Manufacturing Practice (cGMP), analyze all incoming and finished goods and document all work performed. While foods and supplements also have standards set by the FDA, they are not as rigorous, and don’t require pharmaceutical-level standards for testing or manufacturing.
Axcentria is FDA registered (Pharmaceuticals #961871501 and Medical Devices #3008062657) and inspected. Axcentria holds a DEA license.
cGMP refers to the current Good Manufacturing Practice regulations devised by the FDA which require that manufacturers, processors and packagers of drugs, medical devices and some foods and beverages take proactive steps to ensure that their products are safe, pure and effective. cGMP regulations require a quality approach to manufacturing, enabling companies to minimize contamination, mix-ups and errors. This is all designed to protect consumers from purchasing products that are not effective or possibly unsafe.
USP stands for United States Pharmacopeia. This is an official public authority that sets standards for raws materials used in prescription and over–the–counter medicines and other health care products manufactured or sold in the United States.
Absolutely! In accordance with cGMP standards we use a SOP system that controls all our business processes.
We can fill any size between 5ml and 480ml, and can manufacture any size from a pilot batch to commercial scale.
Axcentria owns all product formulas and intellectual property unless there is a licensing agreement where we use your formulas and processing protocols.
The Customer Experience
Axcentria’s expertise is OTC pharmaceutical products and pharmaceutical grade E-liquids. As a full service contract manufacturer, we have extensive experience in:
- Product Development
- Procurement
- Manufacturing
- Product Testing
- Warehousing
- Inventory Management
- Customer Fulfillment
Yes, we have chemists and food scientists that develop and qualify products.
We offer turnkey production from start to finish, produced to your exact specifications.
Of course! Axcentria is extremely flexible and has the capabilities to meet your needs in a variety of ways. We can manage complex arrangements of client supplied API, formulations and components, along with most variations of client supplied vs. Axcentria supplied product builds.
Yes, Axcentria specializes in launches and frequently brings new and innovative products to market. Many markets are changing rapidly and we take pride in being especially nimble and agile, enabling you to successfully enter markets under aggressive timelines.
Our regulatory department is happy to answer any questions you may have to better navigate this complex area.
Each and every client of Axcentria Pharmaceuticals is assigned a Program Manager. He or she acts as your voice and advocate within Axcentria, ensuring your project is completed on time and to your specifications. We are focused on superior customer service and want to meet – and exceed – your expectations.
Sure. We can stock finished goods and dropship inventory based on the conditions of the established supply agreement.
This will vary based on the complexity of your specifications. In general, delivery is quoted as three (3) weeks from the receipt of all components.
OTC and Rx Products
We can manufacture liquids, creams or lotions, whether it’s OTC, Rx or non-regulated.
Put our experience to work for you. Axcentria can assist you in all phases of clinical trials and guide you through the process.
Axcentria can be your partner every step of the way.
Technical Services and Quality
Axcentria Pharmaceuticals provides and documents expiration date and lot coding to all its products.
Axcentria offers fully integrated analytical services that include method development, method validation and testing using the latest analytical technologies. Our cGMP analytical laboratories have efficient and flexible quality systems aligned with our project management, formulation development and manufacturing operations.
All products manufactured by Axcentria are tested according to specifications for:
- Appearance
- Physical properties
- Potency of ingredients
- Impurities
Microbiological tests are required to ensure that our quality control of the product is maintained throughout the manufacturing and packaging processes without any microbial cross contamination. The FDA has pre-established total microbial contamination limits and identification of specific organisms to reduce consumer risk.
Axcentria offers stability storage and testing requirements. We offer ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) and customized storage conditions. Our stability chambers have monitoring with redundant systems, backup power and comprehensive disaster recovery plans.
We can provide test reports or Certificates of Analysis as needed.
E-Liquids
E-liquids are not nationally considered ‘Regulated Products’. However, that status is under review by the FDA and E-liquids may face regulation in the future. Additionally, individual states and governmental entities below the state level have begun instituting regulations of their own, so those will vary by market region.
Not easy to say. The sales level of particular flavors changes, depending on the customer/distributor, marketing strategy, target demographic, sales region and the ever-evolving trends in consumer taste.
We’re writing the book on flavors! We have a large portfolio of flavor creations ranging from standard classics to the more complex and esoteric.
Our Tech Services department will be happy to work with you to develop flavors that suit your needs. Put our imagination and expertise to work for you.
Bulk, bottles or cartridges: Axcentria is able to fill most standard bottles and bottle sizes and 1-3ml cartridges (clearomizers and cartomizers).
Axcentria works with a broad array of packaging manufacturers to achieve the image you want to most effectively engage your customer. We have a variety of packaging options, from standard to customized.
Axcentria is way ahead on this issue. We’ve worked with our partners to completely eliminate these components from our flavorings.
Absolutely. We will formulate to your desired level in any of our flavor offerings.
The use of HPLC or High Pressure Liquid Chromatography is preferred to Titration analysis for e-liquids as they may have a significant amount of interfering substances (i.e. flavors) in their composition. The HPLC is a reliable method of analysis because it can affect rapid separation of components with high resolution and fast analysis time.
The titration analysis is based upon a known chemical reaction with only one specific component (i.e. Nicotine) dissolved in the e-liquid solution. Titration technique is prone to interferences as it is not selective to a specific compound, nor does it quantify if any degradation of the Nicotine has occurred.
Every ingredient we use is tested to USP standards (or applicable standards as required). Each one is evaluated by both the supplier and Axcentria’s lab to ensure its purity and quality. The presence of any of those substances in an ingredient would eliminate its use. Our bottles and caps are held to an equally high standard of cleanliness and materials content. However, Axcentria cannot control the choice of hardware and device used by the customer. Inferior grade hardware is often the source of these contaminants.
We do not produce or distribute the hardware used for the enjoyment of E-liquids. However, as your manufacturing partner, we are happy to share sourcing with hardware suppliers with whom we have relationships.
306 Keystone Drive Telford, PA 18969