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Manufacturing

At Ofogh Pharma Pharmaceuticals, we listen to you first. The success of any outsourcing project depends on a close, flexible relationship between both parties at the highest levels to achieve mutual success. We have a proven capability of developing a process that is robust, transferable, and scalable to meet your contract manufacturing requirements.

We focus on quality and compliance. These topics are now “top of mind” across the industry. The bar is being set higher for every pharmaceutical manufacturer and especially sterile fill pharmaceutical manufacturers. FDA and EMA have created a working environment that is witness to daily changes in regulations and guidelines resulting in increased costs and pharmaceutical plant closures.

Ofoghpharma Pharmaceuticals has a well-established facility and standard operating procedures to meet CGMP and Eu Gmp requirements. Our policies and procedures encompass all of the training, validation, manufacturing, and testing that provide our drug manufacturing outsource customers a cohesive regulatory compliance environment they can trust.

As your contract manufacturing organization, Ofoghpharma Pharmaceuticals can leverage its capital investment and investment in human resources to reduce your cost, time-to-market, and risk to bring a new drug to market or to maintain your current product.

Ofoghpharma Pharmaceuticals can also provide our knowledge in regulatory affairs and the facility/production capability to submit ANDAs on your behalf.

Ofoghpharma Pharmaceuticals is much more than a “white powder, white pill” Contract Manufacturing Organization. We offer many services that other Contract Manufacturing Organizations do not.

Solutions and Services

Capabilities

Product Development
Whether you are new to the pharmaceutical industry equipped with just an idea or a seasoned veteran of the industry, we are here to tailor our capabilities specific to your needs. We are here to be your partner through the product development process as your product's success is our success. As a company, we have successfully developed and launched multiple products into the pharmaceutical market to include New Drug Applications, Abbreviated New Drug Applications, and Drugs to be used in Clinical Trials. Each launch is met with its own set of challenges and intricacies that our seasoned team will meet head-on for you. Rest at ease knowing that you are good and capable hands.
Quality Assurance & Control
Quality Assurance and Control is paramount at our facilities as the safety of the public is at the pinnacle of importance. Our quality systems, which were developed, around Current Good Manufacturing Practices among many others, to ensure the safe delivery of a drug to a patient is in need. We set our quality levels high and are able to sleep soundly at night.
Laboratory Testing
In-depth and diverse internal lab capability on-premise. Some of the testing capabilities include microbiology testing, water for injection testing, incoming raw material testing, finished product testing, clean room environment testing, sterility, chemistry, and physical testing. We also have established relationships with local laboratory testing facilities for any other unique tests that may need to be run.
Regulatory Compliance
Current Good Manufacturing Practices (CGMP) European Good Manufacturing Practices (EUGMP) Drug Supply Chain Security Act (DSCSA) Manufacturing Compliance Product/Lot level Tracking Compliance Serialization Tracking Compliance Packaging Compliance
Marketing Development
Dedicated marketing team at your disposal with decades of experience in the pharmaceutical market for branding, messaging, pricing, and taking your product to market. Experts in everything you need to take your product to the market segment of your choosing: Government Hospitals Physician Pharmacy Consumers
Selling Your Product
Dedicated wholesale distributor licensed for the national and international sales force and distribution direct to the customer or to other wholesalers in the market segment. No matter what the means of distribution for your product is needed, we are able to provide the solution. Distribution to Major Wholesalers Dropship Capability Third-Party Logistics (3PL) Direct to Consumer Private Wholesale Distributor Types of Developed PR