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Pharma

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

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.
Pharma

Does Roquette as a manufacturer has to perform identification tests?

No, following IPEC guideline on certificate of analysis.
Pharma - General regulatory

Do Roquette’s liquid sorbitols comply with the USP/NF monograph?

Liquid sorbitol solutions contain not only sorbitol (D-glucitol) but other related hydrogenated oligomers and polymers of dextrose. All Roquette liquid sorbitols for pharmaceutical applications conform to either the USP or the NF monograph.
For historical reasons the USP monograph defines D-glucitol-rich solutions, commonly known as Crystallising Liquid Sorbitol, as containing a minimum of 64% of D-sorbitol w/w, whereas the NF monograph defines a lower-content D-glucitol syrup, known as Non-Crystallising Liquid Sorbitol, with a minimum content of 54% of D-sorbitol.

For more information on NEOSORB® Liquid sorbitol, please use our Products & Applications selection page.

Pharma - General regulatory

Do Roquette products comply with Pharmacopeias?

Roquette products conform with the current monographs of the three reference Pharmacopoeias (USP, EP, JP/JPE). If no monograph is available, Roquette can establish the appropriate specifications.

For more information on this issue, please contact us or your local representative.
 

Pharma - General regulatory

Is DMF documentation available for Roquette products?

Roquette has issued several DMFs for excipients or active ingredients;
Access to these DMFs can be given upon request.
Not all excipients or actives need a DMF so Roquette has developed alternative procedures that provide access to the information required by the regulatory authorities.

For more information on this issue, please contact us or your local representative.
 

Pharma - General regulatory

What documentation is available for the CTD (Common Technical Document)?

Roquette can provide all the information requested  in the standard Common Technical Document (CTD). However, in order to simplify the customer’s NDA files, Roquette has not only submitted several DMFs to the US authorities but also several CEPs (Certificate of Suitability to the monograph) to the European Medicinal Authorities (EDQM). Roquette DMF and/or CEP Access Letters are therefore available to the NDA applicant upon request.
Moreover, in connection with the New Pharmaceutical Affairs Law (New PAL), implementation, Roquette is preparing new DMF submissions to the Japanese authorities.

For more information on this issue, please contact us or your local representative.
 

Pharma - Packaging - Storage conditions

What are the required storage conditions for Roquette products?

Most of Roquette’s products are well known and their stability when stored in the original sealed packaging established over many decades. The standard storage conditions apply to these products, i e normal temperatures and cool, dry conditions. 
For certain products there might be a need for special temperature or care measures to counter humid conditions. For full details please consult the relevant product specification sheet.

For more information on this issue, please contact us or your local representative.
 

Pharma - Quality status

Are Roquette products GMO-free?

Roquette manufacturing in Europe is exclusively GMO-free, backed up by third-party certification of maize or corn supply.

For more information on this issue, please contact us or your local representative.
 

Pharma - Quality status

What documentation is available for the CTD (Common Technical Document)?

GMP, or Good Manufacturing Practices, are a set of official production standards and as such only make sense when the appropriate reference is indicated. Probably the most widely recognised GMP standards for active ingredients are the ones defined by the US FDA under  legislation  21 CFR, part 210-211. For instance, ROQUETTE’s LYCADEX PF has been assessed on a repeated occasions and has met these standards. However, there are other institutions that have set different GMP guidelines, such as WHO and IPEC.  The question of GMP certification has to be considered in the context of the specific product and local regulatory requirements.

For more information on this issue, please contact us or your local representative.
 

Pharma - Quality status

Do Roquette APIs conform to ICHQ7A?

The implementation of the new European Pharmaceutical Directive (2004/27) have come into force on October 30, 2005. After that, each Active Pharmaceutical Ingredient will have to follow Good Manufacturing Practices according to the International ICHQ7A reference system. Roquette is therefore preparing to apply this quality reference system to its active ingredients.

For more information on this issue, please contact us or your local representative.
 

Pharma - Stability or tox studies

Are stability studies available for Roquette's APIs?

Most of Roquette's products – and their stability – have been established over many decades and are well known. That stability has been once again confirmed by recent studies.

For more information on the toxicological status of a particular product please contact us or your local representative.

Pharma - Stability or tox studies

Are there toxicological studies available for Roquette products?

Roquette has long experience in the manufacture of active and inactive pharmaceutical ingredients. Most of these products are commonly sold as additives or ingredients to the food industry. They do not therefore require specific toxicological studies. The other non-“food grade” types are covered by toxicological studies. 

For more information on the toxicological status of a particular product please contact us or your local representative.

Performance materials - Safety

Are POLYSORB® isosorbide-based polymers considered as bio-based polymers?

POLYSORB® isosorbide is a bio-based monomer.

However, polymers based on isosorbide are produced with other co-monomers.

It is recommended to contact the resin manufacturer to have more information of final bio-based content of the material.
Performance materials - Polymer performance

Are POLYSORB® isosorbide-based polymers UV resistant?

Thanks to its non-aromatic (cycloaliphatic) structure, POLYSORB® isosorbide does not introduce into polymers UV sensitive bonds, enabling higher UV resistance to plastics.

Performance materials - Polymer performance

What is the difference between standard polycarbonate and POLYSORB® isosorbide-based polycarbonate?

Standard polycarbonates are mainly composed of Bisphenol A, while by using POLYSORB® isosorbide, resin manufacturers can design special BPA-free polycarbonates.
Performance materials - Polymer performance

How can POLYSORB® isosorbide contribute to replace standard polycarbonate?

Using POLYSORB® as co-monomer in polyester resins like PET enables to create better performing materials.

With such improvement, they can pretend to be a BPA-free, safe plastic alternative to standard polycarbonate.
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