Manufacturing pathway
Loan licence pharma manufacturing in India
Under a loan licence, your company holds its own manufacturing permission and produces at another licensed manufacturer's facility — Rule 69A of the Drugs Rules, 1945 for most drugs, or Rule 75A for Schedule C and C(1) drugs. More control than third-party manufacturing, without building a plant.
For brands stepping up · licence applicants without a plant · manufacturers with capacity
Your licence. Their facility. Your product.
A loan licence separates the permission from the premises. Your company holds the manufacturing licence for its products; a licensed host manufacturer provides the premises, equipment and staff where they are made. In standard third-party manufacturing, the manufacturer holds the licence and you buy the product for your brand.
Your company
Holds the loan licence
Form 25A for most drugs, or Form 28A for Schedule C and C(1) drugs — and the regulatory responsibility for the products made under it.
Host facility
Provides the licensed plant
Premises, equipment and staff at a licensed manufacturer the licensing authority has assessed as adequate for the products concerned.
One line to remember: your licence, their premises — and both must stay compliant.
Who this route fits
Brand owners ready for more control
You have worked with third-party manufacturing and want your own manufacturing permission next — with the obligations that come with holding it.
Licence applicants without a plant
Your company is applying for — or holds — a loan licence but has no premises of its own. A licensed host facility gives you manufacturing capacity without building one.
Licensed manufacturers with capacity
Your licensed sections have room. Loan-licence arrangements can put spare capacity to work, under agreements that set out who is responsible for what.
Where PharmXchange fits in
Your capability, recorded
A manufacturing account records your facilities and lines, dosage forms and manufacturing scope — the facts a manufacturing conversation starts from.
Verification before quoting
Only fully verified manufacturers receive requirements and quote. Identity checked, licences on file, manufacturing scope declared — a document check, not a facility audit or a regulatory approval.
Demand arrives structured
Buyers and brands post structured requirements on the platform. Matching finds relevant manufacturers, and fully verified ones receive them and can quote without spending PharmXCoins.
The boundary, plainly: PharmXchange facilitates discovery and connections between verified businesses. It is not a party to licences, agreements or manufacturing, and it does not settle transactions.
Key considerations before you commit
01
It is a State Licensing Authority application
Apply under Rule 69A (Form 24A) for most drugs, or Rule 75A (Form 27A) for Schedule C and C(1) drugs. The licence is issued in Form 25A (Rule 70A) or Form 28A (Rule 76A) and relates to a specific host facility.
02
The host facility is assessed too
Before granting a Rule 69A loan licence, the licensing authority must be satisfied that the host unit's equipment, staff, capacity and testing are adequate — so the host's standing matters to your application.
03
Both licences must stay in order
Products made under your loan licence are your regulatory responsibility, and the host must keep its own licence and premises compliant. How obligations divide in practice is a question for regulatory advice.
04
Validity is maintained, not assumed
Under the Rules, a Form 25A loan licence stays valid while its retention fee is paid on schedule (Rule 73AA). Diarise it from the day the licence is issued.
05
Agreements protect both sides
A clear commercial and quality agreement between loanee and host — responsibilities, batch documentation, audit access — is what keeps the arrangement workable.
This is high-level orientation from the Drugs Rules, 1945 as compiled by CDSCO — not legal or regulatory advice. Outcomes depend on your actual application, premises and documentation with the licensing authority.
Loan licence vs third-party manufacturing
Also written loan license — same model, two spellings. The real choice is whether you want to hold the manufacturing licence yourself.
Loan licence
Third-party manufacturing
Manufacturing permission
Loan licence:Yours — Form 25A (Rules 69A/70A), or Form 28A (Rules 75A/76A) for Schedule C and C(1) drugs
TPM:The manufacturer's own licence
Where production happens
Loan licence:At a licensed host manufacturer's facility
TPM:At the manufacturer's facility
Control over the product
Loan licence:More direct — the product is made under your licence
TPM:Through your specification and agreement with the manufacturer
Regulatory obligations
Loan licence:You carry the licence obligations; the host keeps its own licence compliant
TPM:Sit with the licence holder; confirm your own obligations as the brand owner
Documentation load
Loan licence:Heavier — licence application, product permissions, agreements
TPM:Lighter — commercial agreement and artwork
Best suited for
Loan licence:Companies building a manufacturing footing of their own
TPM:Brands that want the product without holding a manufacturing licence
Want the route without holding a licence? See how third-party manufacturing works on PharmXchange →
Why manufacturers build their presence on PharmXchange
Structured demand
Buyers and brands post structured requirements — stated quantities and comparable asks, not scattered enquiries.
Capability recorded once
Facilities and lines, dosage forms and scope are recorded in your account, so each conversation starts from the same facts.
Verification status on your quotes
Buyers see your verification status alongside your quote, so the basics do not have to be re-established every time.
A quote flow, not cold calls
Relevant requirements arrive through the platform once you are fully verified. Quoting never uses PharmXCoins, and contact details are shared only at connect — no brokerage.
Common questions
What is a loan licence in pharma manufacturing?
A licence, granted by the State Licensing Authority, that lets your company manufacture its products at another licensed manufacturer's facility. For most drugs it is applied for under Rule 69A and issued in Form 25A (Rule 70A); for Schedule C and C(1) drugs, under Rule 75A and issued in Form 28A (Rule 76A).
How is a loan licence different from third-party manufacturing?
Under third-party manufacturing the host makes your product under its own licence and you buy it for your brand. Under a loan licence — also written loan license — the manufacturing permission is yours: more control and regulatory involvement, at the cost of more documentation and responsibility.
Who applies for the loan licence, and where?
Your company applies to the State Licensing Authority, and the licence relates to a specific host facility — for a Rule 69A licence the authority must be satisfied the host unit's equipment, staff, capacity and testing are adequate. It is issued in Form 25A, or in Form 28A for Schedule C and C(1) drugs.
Do I need the loan licence before I approach a host facility?
Usually the facility comes first — the application itself names the host premises, so identifying a willing, suitably licensed facility is normally the opening move. Where you are in that process shapes the conversation.
How does PharmXchange help with loan-licence manufacturing?
Manufacturers create an account, get fully verified and record their facilities, lines and dosage forms — only fully verified manufacturers receive requirements and quote. Businesses exploring the route can talk to our team. PharmXchange facilitates discovery and connections; it is not a party to licences, agreements or manufacturing.
Get started
Build your manufacturing presence.
A manufacturing account records your facilities, dosage forms and scope, so that once you are fully verified, relevant requirements in your plan’s markets can reach you.