Contract development and manufacturing of finished dosage forms for the Iranian market: one project team from formulation and technology transfer to IFDA registration and supply.
Contract development and manufacturing
A finished dosage form reaches patients only when formulation, analytical methods, scale-up, stability, packaging, regulatory approval and supply all line up. Hanpars puts one project team in charge of that chain and works with qualified development and manufacturing partners in China, Türkiye, India, Europe and Iran.
We plan every project around the market it is meant for, so the batches, the stability programme and the dossier are built for IFDA review from the start rather than adapted afterwards.
Most projects start from one of three positions. The work behind both is the same: a clear brief, the right partner and a dossier built for Iran.
For manufacturers with an approved product who want registration and sales in Iran, through import or, where policy favours it, local manufacturing by an Iranian partner.
For Iranian companies that need a formulation developed, a product manufactured under contract, or a second source qualified outside Iran.
For originator and large generic companies whose products are better placed being manufactured under licence on the lines of an Iranian GMP plant: the licensor keeps the brand and the know-how, the Iranian plant manufactures, and Hanpars structures and runs the arrangement.
Reference product, patent and data position, IFDA requirements, pricing context and the most realistic path to approval.
Shortlist of GMP sites with the right technology and capacity, document review and audit coordination before any commitment.
Pre-formulation, formulation, method development and validation, comparative dissolution and bioequivalence planning.
Transfer protocols, exhibit and process-validation batches, with change control and records kept to one standard.
Stability studies for the intended climate and shelf life, and a CTD dossier assembled for IFDA review.
IFDA submission and IRC, launch supply, variations, renewals and pharmacovigilance after approval.
Every project passes through the same five gates. Each one ends with a written decision before money is committed to the next.
Product, strength, target market, volumes and timeline; NDA signed before technical data is shared.
Regulatory route, partner shortlist, indicative timeline and the main risks, in writing.
Partner qualified, responsibilities and quality agreement set out, transfer and development plan agreed.
Development, exhibit and validation batches; stability started; dossier compiled section by section.
IFDA submission, questions answered, IRC issued, launch supply and lifecycle management.
Immediate- and modified-release tablets, film-coated and orally disintegrating tablets, hard capsules.
Ampoules, vials and lyophilised powders; prefilled syringes with suitable partners.
Oral solutions, suspensions and syrups; creams, ointments and gels.
We work where the technology and the regulatory record are strongest for each product.
Large-scale CDMO capacity and API integration; NMPA has been an ICH member since 2017.
TİTCK has been a PIC/S participating authority since 2018; short land logistics to Iran.
Local GMP manufacturers for technology transfer and production under licence.
Iran manufactures most of the medicines it uses, and policy consistently favours local production. For many foreign products the realistic long-term route is therefore not import but manufacture under licence by an Iranian GMP plant, with the foreign company remaining the owner of the brand, the formulation and the quality standard.
Locally manufactured products are treated more favourably in registration priority, pricing and insurance coverage than the same product imported.
Production inside the country shortens lead times and removes the product from import-licence and foreign-currency cycles.
The licensor approves the site, the transferred process and every change; batch release follows its specifications and audit rights are written into the agreement.
Iran has a large base of GMP-licensed manufacturers covering oral solids, injectables, liquids and semi-solids, several with experience of manufacturing for international licensors.
Hanpars is the coordinator and, where agreed, the licensee or commercial partner; manufacturing responsibility stays with the licensed Iranian plant under its own manufacturing licence.