Company

Venipharm is an independent, flexible and strongly customer-orientated company dedicated to generics

3 areas of activity

We develop and license out our own generic dossiers
We offer cooperation opportunities to manufacturing partners wishing to register and distribute their pharmaucetical products in the French & EU markets
We propose services in Regulatory and Lifecycle managment Get more infos

We are a French registered pharmaceutical company, experts on the European markets. Venipharm is particurarly well positioned to apply for and license out marketing authorizations with long-term supply of finished dosage forms.

Our company is made up of a dynamic team of chemists, pharmacists and engineers specialized in product development and regulatory affairs, who have acquired an outstanding reputation with customers and partners over the past fifteen years.

Expertise

From market evaluation to marketing authorization

Own developments

Venipharm is a pharmaceutical generic development company investing in our own projects and providing the generic industry with niche products.

Partnerships

The company starts collaborating with manufacturing partners at any stage from R&D to compiled registration dossiers to obtain marketing authorizations in the most efficient way.

Over 15 years experience in

Monitoring of development projects of pharmaceutical forms:

patent evaluation, API selection, formulation, manufacturing process development, ICH stability studies, bioequivalence studies and drafting of dossiers.

Complete assesment of registration dossiers:

ASMF, quality part of finished product, pharmacokinetic studies.

Regulatory strategy of dossier submission:

European procedures (DCP, MRP), national registrations in France.

From licensing out to finished product

Deep and thorough market evaluation

Venipharm identifies business opportunities and coordinates the negotiations until the signing of marketing authorization licenses and finished dosage forms supply agreements with reputed generic companies.

Technical and regulatory assistance

Our experts provide assistance to the generic companies until the products are successfully launched.

Contract manufacturing of finished product

Venipharm is well aware that lifecycle management is a key point in the generics industry. Having a worldwide technical, regulatory and business experience with both pharmaceuticals and API manufacturers, Venipharm assists customers in transferring their products to cost effective manufacturing partners in order to maintain long-term competitiveness.

Available Dossiers

More than 220 MAs from around 50 different molecules already been granted

Abacavir/Lamivudine 600mg/300mg, tablets
Cefpodoxime Proxetil 100mg, tablets
Cefpodoxime Proxetil 40mg/5ml, powder for oral suspension
Cicletanine 50mg, capsules
Ciclopirox 8%, medicated nail lacquer
Ciclopirox olamine 1%, cream
Ciclopirox olamine 1.5%, shampoo
Cyamemazine 25mg and 100mg, tablets
Desloratadine 5mg, tablets
Ebastine 10mg, tablets
Ebastine 10mg, orodispersible tablets
Emtricitabine/Tenofovir 200mg/245mg, tablets
Fluconazole 50mg/5ml, powder for oral suspension
Glucosamine 625mg, capsules and tablets
Ketoprofene retard 100mg, tablets
Lansoprazole 15mg and 30mg, orodispersible tablets
Levetiracetam 250mg, 500mg and 1000mg, tablets
Metformin 500mg, 850mg and 1000mg, tablets
Montelukast 10mg, tablets
Montelukast 5mg, chewable tablets
Olanzapine 5mg, 7.5mg and 10mg, tablets
Olanzapine 5mg and 10mg, orodispersible tablets
Ondansetron 8mg, tablets
Ondansetron 8mg, orodispersible tablets
Paracetamol/Cafeine/ Codeine, 400mg/ 50mg/20mg, tablets
Pinaverium 100mg, tablets
Risperidone 1mg, 2mg and 4mg, tablets
Tenofovir 245mg, tablets
Tramadol/Paracetamol 37.5mg/325mg, tablets
Trimetazidine 35mg, MR tablets
Valproate semisodium, 250mg and 500mg, enteric coated tablets
Valproate Sodium/ Valproic acid 500mg, MR tablets

More than 20 products under developmentNeed further infos?

Contact us

Regulatory Services

Regulatory Affairs, a pivotal role within the pharmaceutical company

Venipharm’s expertise for the Regulatory Services includes:

Registration phase with the Health Authorities Registration dossier creation -

Coordination / preparation of module 1 documents (administrative phase)

  • Coordination of translation activities (product information)
  • Coordination of readability tests for Patient Information Leaflet
  • Gathering of quality documentation (GMP certificates, API and finished products statements, PSMF)
  • Preparation of cover letters and electronic Application Form

Coordination / preparation of module 3 (quality) and module 2.3 (QOS)

  • Complete writing or evaluation of Module 3.2.P and exchanges with European and third country production sites
  • Complete writing or evaluation of module 3.2.S (ASMF, CEP) and exchanges with API manufacturers and external experts
  • Complete writing or evaluation of module 2.3 (QOS)
MA Submission -
  • MA submission: National and European procedures in electronic format
  • Follow-up and communication with the Health Authorities during evaluation phase
  • Answers to Health Authority questions
Post-MA activities / Product Lifecycle Management Preparation and submission of price request dossiers for generic products - Writing and submission of variation applications -

Gathering and assessment of data/preparation of variation applications

  • Pharmaceutical part: update of modules 3.2.P, 3.2.S (ASMF, CEP) and of module 2.3 (QOS)
  • Pharmacokinetics / bioequivalence part: update of modules 2.5 and 5 in relation with pharmacokinetic experts
Pharmaceutical documentation compliance and audit -

Audit of MA dossiers in conjunction with manufacturer’s data (gap analysis) and compliance activities of the pharmaceutical documentation

Preparation and submission of MA renewals (France and Europe)
Development phase
  • Pharmaceutical development: sourcing of API (chemical origin) via the sister company Hepartex and audit of the ASMF
  • Expertise in the resolution of galenic development issues
  • Expertise in the evaluation of analytical validation reports
  • Writing of IMPD for bioequivalence study applications
  • Expertise in the resolution of recurring industrial problems, Troubleshooting
  • Writing of ICH stability protocols and follow-up of studies over time
Miscellaneaous
  • Formatting activities in electronic format

For more information please contact

Chérif Bouaraba cherif.bouaraba@venipharm.com - Phone: +33 (0) 1 47 11 04 47

Hepartex

Discover our sister company Hepartex

Who is Hepartex

Hepartex is expert in APIs for the pharmaceutical industry. Hepartex is an independent, flexible and strongly customer-oriented marketing and sales organization with more than 40 years of experience in the supply of all Heparin salts and a broad range of APIs.

What we offer?

The company offers a range of services that cover the entire value chain, such as: active promotion and distribution of APIs, technical & regulatory services, supply chain & logistics.

Contacts

We look forward to helping you find the right solutions

Venipharm's headquarters

Venipharm

422, les Bureaux de la Colline

92213 Saint-Cloud, France

Phone: +33 1 47 11 04 47

Fax: +33 1 47 71 16 98

Email:

We are constantly searching for talented people to join us. Please send us your application.

Be part of the team