Complex Generics – The Advanced Drug Manufacturing
Changing lifestyle and the rise in diseases has fled the demand for generic medicines.
The emerging economies rely on generic drugs for affordability and availability.
The generic drugs offer cost-effective alternatives with the same clinical outcomes.
The healthcare system is shifting towards precision and targeted therapies.
Pharmaceutical manufacturing is transitioning to develop advanced therapy medicines and complex generics.
Complex generics are generic drugs, manufactured with the latest advancements in novel drug delivery systems, offering a targeted approach.
Aprazer Healthcare – The Generic Drug Manufacturer
Aprazer Healthcare is at the forefront of manufacturing advanced drugs.
- Complex generics
- Branded generics
Leveraging cutting-edge technology, we manufacture the new treatment drugs.
We specialize in manufacturing –
- Modified release tablets/capsules.
- Pre-filled syringes
- RTU technology injections
We are generic drug manufacturers; we are global exporters of a large range of pharmaceutical products.
What are generic drugs?
Generic drugs are medicines that are brand equivalent.
They have the same therapeutic efficacy, safety, and strength as the branded drugs.
Branded drugs are patent medicines manufactured or invented by the company that owns the patent.
These are developed by extensive research and the drug development process.
The manufacturing company retains the rights to manufacture the drug.
They are higher in cost.
What are complex generics?
These are the brand equivalent drugs that contain complex APIs, formulations, and dosage forms.
The various forms include-
-
- Complex dosage forms – Transdermal patches
- Drug – device combination – Inhalers, Auto-injectors
- Complex API – Peptides, liposomes
- Modified release mechanisms- controlled release formulations
- Locally acting drugs – creams, ophthalmic preparations, etc.
Challenges in manufacturing complex generics
The manufacturing of advanced therapy drugs involves both technological and regulatory advancements.
The hurdles faced in manufacturing complex therapeutics include-
Technical complexity –
Manufacturing complex products requires complex equipment and advanced technology.
It requires multi-step controls and testing compared to standard medicines.
Clinical studies required – The development of a complex system requires human trials compared to a conventional drug system.
Patent hurdles – Manufacturing device combination may include a patent or copyright for the use of a device component or parts.
Undeveloped regulatory standards – The regulatory systems are not developed to approve advanced drugs. It leads to delays and failures.
Scale up and process consistency – scaling up complex manufacturing processes and maintaining consistency add up to the rigor.
The development of complex therapeutics requires high investment costs.
Aprazer Healthcare is the leading manufacturer of complex generics.
With world-class infrastructure, Aprazer Healthcare aligns with the latest technological advancements.
