American Injectable

A privately held Florida based domestic manufacturer of injectable drug products.

We help our local and international customers develop, transfer, and commercialize essential injectable products at affordable rates while maintaining the highest quality and supply chain dependability. Let us be your One Partner, whether you have a mature product that needs a new home or development. Most injectable drugs used in the United States are made in other countries. With our contract development and manufacturing infrastructure, we are changing that by bringing critical injectable products back home. American Injectable is a sterile injectable producer established in the United States that focuses on ready-to-use pre-filled syringes and vials. The company’s pipeline contains small molecule 505(b)(2) NDA and 505(j) ANDA syringe and vial medicines, and it acts as a critical pharmaceutical company’s outsourced contract manufacturing partner.

learn more

Product Development

Method development for analytical and micro
Lab scale stability
QbD holistic approach
Filter selection and compatibility
Formulation development

Tech Transfer

• Rapid site transfers of already developed or commercialized injectables Tech transfer team with optimized and proven transfer plans
• ICH stability studies
• Full analytical and micro capabilities

Drug-Device Specialists

• Experts in drug-device combination product development Ready-to-use devices such as pre-filled syringes or pens
• Fully compliant 21 CFR Part 4 simplified QMS

Drug-Device Specialists

• Experts in drug-device combination product development Ready-to-use devices such as pre-filled syringes or pens
• Fully compliant 21 CFR Part 4 simplified QMS

Fill-Finish

• 2R-50R RTU tray vial glass or plastic
• 1 mL, 1-3 mL, 5 mL, 10 mL, and 50 mL RTU nested syringes
• 1.5 mL and 3 mL RTU cartridges
• Peristaltic and rotary piston pump filling
• Pre-configured for very viscous

Device Assembly

• Cartridge device assembly in 1.5 and 3 mL forms
• Device agnostic
• Space and choices for fully automated high-volume assembly

"They produce quality medicine."

Muhammad Aamin

"Good factory to get job."

Rehman khan

"It is a Private Pharma factory not Public place. "

Muhammad Faisal Naveed

24/7 we care about client Satisfaction

Learn MoreLearn More

Call Now: +18134356014

Our Employee

Our Core Members

VIJAY NEKKANTI

American Injectable

TRAVIS ALLEN

American Injectable

BEN BOLING

American Injectable

ADAM LEVITT

American Injectable

FAQS

What is a device assembler?

The Medical Device Assembler is responsible for creating, testing and documenting sub-assemblies and top-level systems for Production. Medical device manufacturing is the assembling of mechanical components as well as the integration of electrical components.

What is the difference between a medical device and a drug?

Pharmaceuticals are chemicals intended to interact actively with the body’s metabolic or immunological systems. Drugs either work or they don’t. Effectiveness is quite simple to demonstrate. Devices are primarily mechanical and have little impact on the human body.

What is Packaging and Serialization?

Serialization in pharmaceutical packaging refers to providing unique markers to each product’s package design. It is critical to combat counterfeiting. For barcode scanning, individual goods, cases, or pallets can be serialized by labelling.

What does tech transfer do?

What is technology transfer? – Tech Transfer Central In research institutions, technology transfer (or tech transfer) is the process through which new ideas and other discoveries developed in such institutions’ labs are converted into products and commercialized.

need any help?

We’re here to support you every step of the way. Reach out to us and let us help you succeed.

get in touch with us

Contact us to start building a powerful digital presence for your business today. Our team of experts is ready to provide you with customized solutions tailored to your specific needs. Let us help you achieve your digital marketing goals and stand out from the competition.

Call Us Now: +18134356014

Email Now: [email protected]

Office Address: 15261 Telcom Dr, Brooksville, FL 34604

Are you ready to sell your property?

American Injectable: US-based sterile injectable producer, bringing critical injectable products back home through contract development and manufacturing infrastructure.