Looking for product documentation? Want to order a sample?
Watch this video
Video

Can a generic manufacturer use a different ingredient/excipient while still submitting drug as a generic?

See answer
The generic needs to have the same API (Active Pharmaceutical Ingredient) composition (qualitative and quantitative) as the one of the brand leader.
There is no obligation to have the same composition in excipients, even though some generic companies prefer to stick to the same excipients as long as they have the same dosage form.
ex.: immediate release film-coated tablet,  there is no problem to use Lycoat or ReadiLycoat instead of HPMC or PVA  based coating system as long as it has the same functionality.

Other questions - General

Does Roquette as a manufacturer has to perform identification tests?

See answer

How does sorbitol ingestion influence blood glycemia?

See answer

What is the available information on the effect and dosage of polyols on newborn babies during the first months?

See answer

What is the viscosity's of a non-crystalising liquid sorbitol such as NEOSORB 70/70 B?

See answer
Pharma & Nutraceuticals
Know more
Our site uses cookies for web statistics usage and to enhance your user experience. For more information visit our cookie policy and learn how to customize cookies setting.
Click Agree to accept cookies and go directly to the site.
Please, turn your device to portrait mode.