MANUFACTURING

GENERIC DRUGS

 

World-Vet is dedicated to enhancing animal health and welfare with its effective and trustworthy solutions created especially for the field of livestock.

Well-known for its excellence in generic drug manufacturing, World-Vet introduces a large range of high-quality, reliable and cost-effective alternatives for many veterinary products At World-Vet, our dedication to providing high-quality veterinary care is demonstrated by our broad range of more than 40 generic products, ensuring affordability and accessibility for superior veterinary care across the globe.

What exactly are generic drugs?

What are the similarities and differences of generic drugswith the brand-name drug?

Can I trust the quality of a generic drug?

What exactly are generic drugs?

A generic drug is one that is created to be exactly the same as a drug that has already received approval. And they can be used as a substitute for a brand-name drug. They are designed to be as effective as brand-name drugs in terms of dosage, safety, potency, route, quality and performance, as well as intended use. The similarities between a generic drug and a brand-name drug help to prove that a generic works just as well and provides as much clinical benefit as a brand-name drug.

The generic drug should meet the following general requirements:

• Be off-patent
• Have an active substance in a previously approved medicine
• Be bioequivalent to the previously approved medicine
• Have the same dosage form
• Have the same route of administration
• Have the same treatment characteristics

Pharmaceutical Equivalance

• In-vitro equivalance

• It is not necessary to do animal research

• Both original and generic products are made using the same processes and have precisely the same substances at the same concentration.

Bioequivalance

• In-vivo equivalance

• Animal studies are required

• Both original and generic products have the same active components, but the excipients or their concentrations may change.

What are the similarities and differences of generic drugs with the brand-name drug?

Similarities to the brand-name drug :

• Treating the same diseases

• Using the same doses

• Containing the same active substances

Differences from the brand-name drug:

• Drug’s name

• Appearance

• Packaging

Can I trust the quality of a generic drug?

The monitoring and quality assurance protocols persist even after the generic drug receives approval. FDA staff consistently monitors all approved pharmaceuticals, including generics, to ensure the safety, efficacy, and high quality of veterinary drugs throughout every stage of the supply chain, from active pharmaceutical substances to the final products available to consumers.

The post-approval obligations for both brand-name and generic drugs remain consistent, including tasks such as, conducting continuous stability assessments, reporting manufacturing changes, monitoring and reporting adverse events.

Do generic drugs meet the same high-quality standards?

The manufacturer of the generic version should demonstrate that the active substance, dosage form, dosage arrangement and the strength of the generic drug are all the same as those of the authorised pioneer drug in terms of quality, safety and effectiveness. Furthermore, every component should fulfill exacting quality requirements, and the generic needs to show stability over its product lifetime.
 

Why do generic drugs cost less and have a different appearance than brand-name drugs?

Different Appearance

Trademark regulations prohibit generic drugs from appearing identical to existing drugs in the market. While generic and brand-name drugs contain the same active substance, differences in non-essential attributes like colors and flavors, which have no impact on the generic drug's performance, safety, or efficacy, may exist.

Low Price

Generic drugs are often priced lower than their brand-name counterparts because the manufacturers of generic drugs are not required to replicate the clinical studies that brand-name drugs undergo to establish their safety and efficacy. Additionally, when multiple generic companies are authorized to distribute the same product, it leads to increased competition in the market.