Gulf Biotech liquid injectables manufacturing facility is a state of the art designed and equipped facility. We are offering a verity of product types including lyophilized Vials, Cartridges and ampoules as well as specific techniques such as sterile emulsion technology and pre-filled syringes.

ASEPTIC FILLING

We are offering for contract manufacturing of sterile formulations at Gulf Biotech Injectable production facility. Our production facility have a maintained operational Grade A (ISO Class 5) environment for sterile fillings in Vials, Cartridges, ampoules and prefilled syringes. All areas of our aseptic processing facility, including ancillary support areas are designed at FDA and EMEA standards and meet the other highest regulatory standards. our facility is designed in such a way that viable airborne contamination, viable contamination on surfaces and non-viable airborne contamination will be minimum and within the allowed limits.

We are offering following dosage forms for contract manufacturing.

Sterile Liquid Injectable: Our contract manufacturing production capacity  includes, Aseptic fill on a state-of-the-art fill & finish crimp-cap line, capable of aseptic filling 1-20 ml vials and 3-5 ml cartridges with extremely low dead volume. We are able to fill Ampoule under a septic conditions with sizes range from 1-20 ml. In addition, our facility has Lyophilization capabilities and anticipate that we are offering this service for contract manufacturing to our clients now.

Aseptic Syringe Fill: We have capability for filling 2, 3, 5, 10 and 20 ml syringes. our production capacity is calculated around 48 million prefilled syringes per year. The production of sterile prefilled syringes will be with an aseptic filling machine that can handle various aqueous solutions and different syringe formats at a production of 10,000 units / hour.

BENEFITS OF CONTRACT MANUFACTURING

Cost Savings: It is highly cost saving because companies do not need to spend for a facility design, construction, equipment purchasing, installation and maintenance for production saving on Labor cost, salaries, government fees and other indirect costs.

Mutual Benefits: The benefit for manufacturing companies is that they can utilize their space time which they cannot use because of any reason. Every manufacturer know that the profitability will be high if machines are running at optimum level and for maximum time. Companies who are manufacturing products from third party can focus on their other businesses which are their core areas.

Skills & knowledge: Companies can take advantage of skills and knowledge that they may not have but contract manufacturer possesses. The contract manufacturer is also benefited and get knowledge of raw materials, connection with suppliers etc.

Economies of Scale: Contract Manufacturers normally deal with number of customers at the same time for contract manufacturing in order to keep running their machinery for maximum period of time so they can offer very competitive costs in getting materials including packaging and raw materials.

BUSINESS MODEL

In normal practice and a common perception, a hiring company contact to contract manufacturer, ask for quotation and set a formula to deal with each other. contract manufacture usually calculate labor cost, machine depreciation, utilities costs and overheads for the quotation preparation. upon successful signing of agreement, contract manufacturer become like a “rented factory” which will not only produce, pack but also ship products for the hiring company. In actual practice, the pricing formula for contract manufacturing is not so simple, there are number of method for pricing for contract manufacturing.

• Fixed materials pricing model
• Component cost pricing model
• Cost plus pricing model
• Return on invested capital pricing model

Gulf Biotech is open to discuss different pricing models with our valuable customers for contract manufacturing of vials, ampoules, cartridges and prefilled syringes.