Pharmaceutical CDMO Services in India
Development to commercial supply at one WHO-GMP site, Dabkori, Panchkula
Vibcare Healthcare works as a contract development and manufacturing organisation for tablets, capsules, oral liquids and external preparations. Formulation development, technology transfer, analytical method work, stability and registration support run in our own laboratories, and commercial supply runs on our own lines, so one site and one quality unit carry your product from brief to market. For manufacturing of an existing product against a rate, see third party manufacturing.
CDMO at Vibcare Healthcare, by the numbers
What is already in place for a development partner
What we do as a CDMO
Six services, all delivered from Dabkori
Formulation development
Development of the formulation and process on our equipment, from your composition or a reference product, with trial batches on the production-scale granulation, filling and mixing equipment rather than on bench-top substitutes.
Technology transfer and scale-up
Transfer of a product from your R&D or pilot scale, or from another site, with critical process parameters, in-process controls and batch size fixed before the first validation batch.
Analytical development
Method development, transfer, verification and validation in our own GLP certified laboratory, on HPLC, dissolution and UV instruments, for raw material and finished product.
Stability
ICH accelerated and long-term studies in our own stability chambers, with trending and shelf-life data held as records for your registration file.
Regulatory and dossier support
Product permission from FDA Haryana for new formulations, and documentation for domestic registration and export dossiers. Certificates and site documents are supplied for your regulatory filings on request.
Commercial supply and packaging
Manufacture, packing and release on our own lines, with blister and strip foil printed inside the plant on our rotogravure unit, so artwork changes and repeat orders stay on our schedule.
How an engagement runs
Six steps from first contact to commercial supply
- Enquiry. Product, dosage form, target market and intended annual quantity. A confidentiality agreement is signed before any formulation detail is exchanged.
- Feasibility. The formulation is checked against the licence, the equipment and the packaging we hold; anything needing a product permission or a change part is identified now.
- Proposal. Development scope, batch size, lead time, rate and payment terms, in writing.
- Development and transfer. Trial batches, analytical method work and stability set-down, with data shared as it is generated.
- Validation and registration. Validation batches, stability data and documentation for the product permission or dossier.
- Commercial supply. Batch manufacturing record and certificate of analysis with every consignment; repeat orders scheduled against your forecast.
Timelines depend on the dosage form, the stability protocol and the market, and are given with the proposal.
Who we work with
Three kinds of partner, three different briefs
Indian marketing companies
Brands that want a product developed, permitted and supplied under their own name, with pack artwork, foil printing and repeat supply handled at one site.
Institutional and tender suppliers
Suppliers who need pharmacopoeial products manufactured to a specification, with the batch records, certificates of analysis and site documents that tender files ask for.
International importers
Importers registering products in their own market, who need USP or BP monograph products, stability data for the dossier and documentation from the manufacturing site. 22 markets are currently supplied.
Client names are shared on request under a confidentiality agreement, not published.
The site and its compliance
Approvals held by Vibcare Healthcare Pvt Ltd for the Dabkori plant
Sections at the plant
Machines, capacities and approved formulations for each dosage form
Tablets
1.1 billion a year. Granulation, compression, coating, blister, alu-alu and strip packing. 334 tablet formulations on the product list.
Capsules
950 million a year on an ACG AF90T line. Powder, pellet and combination fills. 69 capsule formulations on the product list.
Oral liquids
30 million bottles a year. Syrups, suspensions, solutions and oral drops in HDPE, PET and glass. 85 formulations on the product list.
Creams, ointments and gels
40 million tubes a year. Creams, ointments, gels, lotions and topical solutions. 108 formulations on the product list.
Questions CDMO buyers ask
Before you send a brief
What is the difference between CDMO and third party manufacturing?
Third party manufacturing is supply of a product that already exists, against a rate and a batch size. CDMO adds the development side: formulation and process development, technology transfer, analytical method work, stability and registration support, carried out before commercial supply starts. Both run at the same site.
Can you develop a product that is not on your approved list?
Yes, within the licensed dosage forms. Development runs on our equipment, and the product permission is applied for from the Food and Drugs Administration, Haryana, with the expected timeline given in the proposal.
Who owns the formulation once it is developed?
The formulation, artwork and brand developed for you remain yours. The manufacturing record and site documentation are held by us as the manufacturer, as the licence requires, and are made available for your regulatory filings.
Do you sign a confidentiality agreement?
Yes. A confidentiality agreement is signed before formulation details, reference products or market plans are exchanged.
What is the minimum order quantity?
It follows the batch size, which depends on the composition, the dosage form and the pack. The minimum batch quantity for your product comes with the proposal, along with the rate at that quantity.
Can you support product registration in export markets?
Yes. Stability data is generated in our own laboratories, and site documentation and certificates are supplied for the dossier. 39 export approvals to USP and BP monographs are already on the licence, supplying 22 markets.
Which dosage forms can be developed and manufactured?
General tablets, hard-gelatin capsules, oral liquids and external preparations. Beta-lactam products, soft gelatin capsules and sterile products are not made at this site.
Can we audit the plant?
Yes. Customer audits of the manufacturing blocks, laboratories and documentation are welcome by appointment.
Talk to us about a development project
Send the composition or reference product, the dosage form, the market and the annual quantity. You will get a feasibility view and a proposal in writing.
info.vh@vibcare.co.in · +91 85660 76607 · Khasra 6/2/2, Kot Road, Village Dabkori, Panchkula, Haryana 134103
