Service
Custom pharmaceutical manufacturing, made to your formula
A medicine that is not on anyone's shelf yet, or one you already sell and want made well. Send us your formula, a reference product or just the idea, and Progene Pharma develops it, tests it and manufactures it in a WHO-GMP certified facility, with the stability data and dossier to register it in your country.
- Starting point
- Your formula or a reference product
- Dosage forms
- Tablets to injections
- Development
- Formulation, stability, dossier
- Supply
- Export only, worldwide
What is custom pharmaceutical manufacturing?
Custom manufacturing means a product is made to your specification rather than taken from a manufacturer's catalogue. You say what the medicine must contain, in which strength and dosage form, and the manufacturer develops the formula if needed, makes trial batches, proves the product is stable and then produces it commercially.
It is also called contract manufacturing, custom formulation or contract development and manufacturing. Progene Pharma does the development and the manufacturing in one place, so one team answers for the formula, the quality and the documents.
Who uses custom manufacturing
Any company whose product does not exist in a manufacturer's range, or whose current supplier has let them down.
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Distributors and importers
Get the strength, combination or dosage form your market prescribes, which the big brands do not offer.
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Brand owners
Launch a new product, such as a combination tablet or a paediatric form, under your own name.
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Companies changing supplier
Move a product you already sell to a new manufacturer without changing the formula your customers know.
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Tender suppliers
Meet a ministry's exact specification for strength, pack and labelling, which standard products may not match.
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Health programmes and NGOs
Programme packs, dispersible forms for children and fixed-dose combinations designed for treatment programmes.
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Veterinary and supplement brands
Formulas for animals, supplements and herbal products made to your blend, dose and flavour.
You bring the requirement. We develop and make it.
A clear division of work, so the development risk sits with a team that does it every day.
You provide
- The product: formula, reference product or target profile
- The strength and dosage form
- The country you will register and sell in
- The brand, pack and label language
- The brand and registration in your name
We handle
- Formulation development, or matching your formula
- Trial batches and testing against the specification
- Stability studies for your climate zone
- The dossier, COPP and samples for registration
- Commercial manufacturing in a WHO-GMP certified facility
- Testing and release of every batch, with a COA
What we can make to your specification
If a medicine is approved in your country, we can make it. These are the most common requests.
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A new strength
A dose that standard ranges skip, such as a paediatric strength or a higher strength for your guidelines.
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A combination
Two or more actives in one tablet or capsule, in the ratio your treatment guidelines recommend.
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A different dosage form
A tablet as a dispersible tablet, a syrup as a dry syrup, a capsule as a sachet, to suit your patients.
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A copy of a reference product
A generic equivalent of a product you name, made to the same specification and tested against it.
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Your existing formula
A product you already sell, moved to us with your formula and methods, and made to the same standard.
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Your pack format
Blisters, bottles, sachets, vials or tubes in the pack sizes your customers and tenders buy.
Categories we make to order
Custom manufacturing covers every category we make, not only human medicines. Download the product list (PDF)
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Human formulations
Tablets, capsules, syrups, injections, IV fluids, creams and drops, across every major therapy area.
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Veterinary medicines
Boluses, injectables, oral liquids and premixes for livestock, poultry and pets.
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Nutraceuticals
Vitamins, minerals, omega-3, probiotics and protein supplements in your blend.
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Herbal and Ayurvedic
Herbal blends as tablets, capsules, syrups and powders, in your formula.
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Cosmetic and personal care
Creams, washes, shampoos, soaps and toothpaste in your formula and fragrance.
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DC granules and pellets
Granules and coated pellets in the drug load and particle size you specify.
How custom manufacturing works
The timeline depends on how new the product is and how long registration takes in your country. We confirm it with your quotation.
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01
Send your brief
The formula or reference product, strength, dosage form, pack, quantity and the country you are registering in.
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02
Feasibility and quotation
We check what is needed, then confirm the price, the lead time and the documents your regulator expects.
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03
Development
We develop the formula, or set up yours, and agree the specification with you.
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04
Trial batches and stability
Trial batches are made and tested, and stability studies start for your climate zone.
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05
Register
We send the dossier, COPP and samples, and your company files the registration in its name.
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06
Commercial production
Once approved, we manufacture, test and release each batch, and ship it with every document for import.
Why companies choose Progene Pharma
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Since 2006
Two decades of exporting medicines to distributors in Africa, Asia, Latin America, the Middle East and Europe.
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Development and manufacturing together
One team takes the product from the formula to the finished batch, so nothing is lost between a developer and a factory.
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Certified manufacturing
Progene Pharma manufactures in a WHO-GMP certified facility, also certified to EU-GMP and ISO, matched to the standard your market accepts.
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Registration support
CTD and ACTD dossiers, COPP, stability data and samples, with answers to your regulator's questions.
Questions about custom manufacturing
Something else? Email [email protected].
What is custom pharmaceutical manufacturing?
A product is made to your specification instead of coming from a manufacturer's catalogue. You set the formula, strength and dosage form, and the manufacturer develops it if needed, tests it and produces it, with the documents to register it.
What is the difference between custom manufacturing and private label?
Private label puts your brand on a product from our range. Custom manufacturing makes a product we do not list, to your formula, strength or dosage form. Many orders combine both: a custom product under your own brand.
Can you copy a reference product?
Yes, where a generic version is allowed in your country. We make a generic equivalent to the same specification and test it against the reference. We do not make products that would infringe a patent in the country where they will be sold.
Can you take over a product I already sell?
Yes. Send us your formula and test methods and we make the product to the same standard, so you can change supplier without changing the product your customers know. Some regulators need a variation filed when the manufacturer changes, which your company submits.
Who owns the formula?
A formula you supply stays yours. For a formula we develop for you, ownership and exclusivity are agreed in writing before work starts.
Will you keep our formula confidential?
Yes. Progene Pharma uses your formula, brand and pricing only for your orders, and we sign a non-disclosure agreement on request.
What is the minimum order quantity?
It depends on the product, the dosage form and the packaging. We confirm the minimum quantity with your quotation and work with smaller distributors as well as large importers.
Do you offer custom manufacturing for the Indian market?
No. Progene Pharma's custom manufacturing is for export only. We supply brand owners, distributors and importers outside India.
Explore more
Request a quote
Send us your product requirements and target country. Our team will reply with a quotation and next steps.
- [email protected]
- Phone
- +91 22 49793146
- +91 90829 70494