European Union

EU Partnership

Wockhardt, a pharmaceutical and biotechnology company with over four decades of proven research capability and global presence, provides comprehensive end-to-end solutions ranging from API and pharmaceutical development to product supply.

Our strengths and experience encompass:

  • Product development through multi-disciplinary research activities covering complex API and formulation dose development to CRO activities
  • In-house pharmaceutical development and analytical laboratories enabling speed and control at all critical stages of the product development process
  • Development and scale up of a broad spectrum of dosage forms covering:
      • Tablets & Capsules plain, coated, gastro-resistant, modified, dual & delayed release, bi-layered, multi-layered, tablet in tablet, orally dissolving
      • Sachets
      • Oral Liquids and Suspensions
      • Small Volume Parenteral in ampoules and vials (both in solution and lyophilized) cartridges, pre-filled syringes along with delivery devices like disposable, multiuse and metered pens
      • Ophthalmic and OTIC dosage forms
      • Nasal Sprays
      • Potent products, Controlled substances, Products with alternate salts, Products with device
  • Development carried after thorough analysis of the IP landscape to develop products with non-infringing technologies to minimize the launch risks
  • Understanding of, and sound expertise in, varied global markets' regulatory requirements
  • Experience of having filed multiple DMF’s, EU CTD Dossier and successfully obtaining COS and Marketing Authorization in Europe
  • Manufacturing of products in UK MHRA and US FDA approved facilities
  • Ability to supply EU QP released products within the EU.

Our Focus

  • To develop less competitive, difficult to replicate products involving complex chemistries & technological challenges to gain competitive differential
  • Developing value added generics, niche products, modified release products with controlled & potent substances
  • Develop products involving challenging registration strategies and difficult patent situations
  • Liquids, Injectables and sterile products form integral part of our product portfolio
  • Patient centric development approach and developing products for unmet patient population.

Export Manufacturing Shots

What we Offer

  •  Product Portfolio : Comprehensive bouquet of 100+ products across dosage forms
  • Regulatory : EU CTD Dossier with complete regulatory support for filing
      • Before: Choose the best regulatory strategy and secure DCP slot
      • During : Provide support throughout the entire Marketing Authorization (MA) process
      • After : Once MA has been granted, work alongside customer in making improvements to MA dossier
  • IP : Knowledgeable IP team conversant with global regulatory issues and solutions
  • Supply of Product : Delivery of product on time at right place of required volume with consistent quality
  • EU QP Release : A large Quality Control and Quality Assurance function with EU
  • Quality and Reliability: Delivering quality products efficiently and reliably by continuous investment in R&D and modern manufacturing technologies and machinery, from EU approved facilities
  • Day 1 Launch: Investment in Infrastructure and creation of systems and organization to enable customer to offer a generic version on Day 1 post patent expiry
  • Competitive Pricing : Delivering quality generic medicines cost effectively during the entire product lifecycle by constantly optimizing costs
  • Long term Relationship: Making partner successful in the most competitive, dynamic & demanding world of generics by providing cost effective & value added innovative products & helping partner create long term value.

Overall a Top Quality Dossier, Expert IP advice, Registration and Regulatory Affairs support, Consistent Quality Product Supply, Pricing support and Long Term relationship throughout the product life cycle.

For further details and product list, contact; Tracy Davies Tracy.Davies@wockhardt.co.uk
Suvarna Sonawane ssonawane@wockhardt.com 

Bullet Point EU CTD Dossier List