Generic Pharmaceutical Formulations

How we work in generic pharmaceuticals

India is one of the largest suppliers of generic medicines in the world, and for many importers that scale is the problem rather than the opportunity. There are thousands of manufacturing units of widely varying quality, regulatory standing and export experience, and a quotation received without knowing which unit produced it, what approvals that unit holds and what documentation it can supply is not a usable offer. VP Global Exim works in this category as a sourcing and export partner: we identify licensed manufacturers matched to your product and destination market, and we manage the commercial and documentary side of the transaction.

It is important to be precise about what we are and are not. We are a merchant exporter, not a manufacturer, not a licensed pharmacy and not a regulatory consultancy. We do not manufacture medicines, we do not hold marketing authorisations, and we do not advise on the clinical use, selection, substitution or dosing of any product. Those decisions sit with you, with your regulatory advisers and with the qualified professionals in your market. What we do is connect a defined requirement to a manufacturer that can legitimately fulfil it, and then move the goods and paperwork correctly.

The dosage forms we can source cover oral solids including uncoated, film-coated and enteric-coated tablets and hard and soft capsules, oral liquids including syrups, suspensions and drops, dry powders for reconstitution, injectables in vials, ampoules and pre-filled formats, topical preparations including creams, ointments and gels, and ophthalmic and other specialised forms where the manufacturer holds the relevant approvals and facilities. Availability differs substantially by dosage form, because the facility approvals required differ.

Every enquiry starts with your requirement in writing: the molecule or product, the strength and dosage form, the pack presentation, the annual and per-order quantity, the destination market, and whether the product is already registered there or requires registration. Those last two points determine the whole shape of the project, and an enquiry without them cannot be quoted meaningfully.

Manufacturer selection and licensing

Manufacturer selection is the single most consequential decision in this category, and it is made on evidence rather than on price. We confirm that a unit holds a valid manufacturing licence issued by the competent authority for the specific dosage form and product category, that its Good Manufacturing Practice certification is current and covers the relevant facility and section, and that it holds any additional approvals your market recognises or requires.

Where a destination market requires the manufacturer to hold a specific international approval or to have been inspected by a particular authority, that becomes a hard filter rather than a preference. Many Indian units hold approvals from a range of regulatory authorities, and many do not. We establish which category a unit falls into before offering it, because presenting an unapproved unit for a market that requires approval wastes months and can jeopardise an importer's own licence standing.

Certificates are verified rather than accepted as images. We check licence and certificate numbers, validity dates, the scope of the certified activity and the specific facility address, since a group may hold an excellent certification for one plant and be producing your product at another. Where a buyer's own compliance programme requires audit rights, we support factory audits and third-party assessments, and we will tell you plainly if a manufacturer declines to be audited.

We also confirm the commercial basics that importers frequently discover too late: whether the manufacturer will supply the product under your brand or only under theirs, whether they will provide a dossier and in what format, whether they will act as the named manufacturer on your registration, and whether they have any exclusivity or territorial restriction that affects your market. All four are settled in writing before an order is placed.

Regulatory pathway and market registration

Pharmaceutical products cannot generally be imported and sold on a commercial invoice alone. Most markets require the product to be registered or to hold a marketing authorisation, require the importer to hold a valid import licence or wholesale dealer authorisation, and require the manufacturing site to be recognised. The sequence, the timeline and the documentation differ enormously between jurisdictions, and a project plan that ignores this will fail regardless of how good the product and price are.

We are explicit about the division of responsibility. Obtaining an import licence, securing product registration or marketing authorisation, appointing a local responsible person where required, and complying with the destination market's pharmacovigilance, labelling and distribution obligations are the importer's responsibilities. We do not perform them and we do not represent that we can. What we do is provide the manufacturer-side documentation that a registration application depends on, and coordinate with the manufacturer to answer regulatory queries during the process.

That manufacturer-side support typically includes the product dossier in the format the manufacturer maintains, a Certificate of Pharmaceutical Product where the competent authority will issue one, free sale certificates, manufacturing and marketing authorisation copies, GMP certification, site master file extracts where required, stability data, method validation and analytical procedures, specification sheets for the finished product and for actives and excipients, and batch documentation. We coordinate legalisation, apostille or embassy attestation of documents where your authority requires it.

Realistic timelines matter more than optimistic ones. Where a product is already registered in your market and you hold a current import licence, an order can move on a normal commercial timeline. Where registration is required, the pathway is typically measured in many months and sometimes years, and it must be started before commercial commitments are made. We will tell you when a target launch date is not achievable rather than quoting into it.

Quality systems, testing and batch documentation

Quality in this category is established by the manufacturer's system rather than by inspection of the finished goods, which is why manufacturer selection carries so much weight. We confirm that the unit operates a documented quality management system with defined batch manufacturing records, in-process controls, qualified and calibrated equipment, validated processes and analytical methods, controlled change management and deviation handling, and a qualified person or equivalent responsible for batch release.

Every shipment is accompanied by batch-specific documentation. A Certificate of Analysis states the tested parameters against the registered or agreed specification with actual measured results, covering as applicable identification and assay of the active, related substances and impurities, dissolution or disintegration, uniformity of dosage units, water content, microbiological limits, sterility and endotoxins on sterile products, and physical parameters. A certificate stating only that the product conforms, without values, is not adequate and we do not accept it.

Where your own programme requires independent verification, we arrange third-party laboratory testing on samples drawn from the production batch, and we can arrange pre-shipment sampling and inspection by an agency you nominate. For buyers whose authority requires testing at destination, we plan sample quantities and documentation so the testing can proceed without holding the whole consignment.

Stability and shelf life are handled explicitly rather than assumed. We confirm the assigned shelf life, the storage conditions it is based on, the stability data supporting it, and critically the remaining shelf life at the point of arrival rather than at the point of manufacture. Many markets require a minimum remaining shelf life at import, commonly a substantial proportion of the total, and a consignment that fails that requirement is refused entry. We check the rule for your market and plan production and shipping against it.

Packaging, labelling and serialisation

Pharmaceutical packaging is regulated, not decorative. Primary packaging must be of a specified material and grade compatible with the formulation, secondary packaging must carry the information the destination market mandates, and the whole presentation must match what was registered. A product supplied in packaging that differs from the registered presentation is not the registered product, which is a regulatory problem rather than a cosmetic one.

Labelling requirements vary by market and typically cover the product name and strength, the full composition including excipients where required, the dosage form and pack contents, the manufacturer's name, address and licence details, the importer or marketing authorisation holder details, batch number, manufacturing and expiry dates in a specified format, storage conditions, prescription status and any mandated warnings, the barcode or unique identifier, and the required language or languages. We confirm the requirement list for your market and have artwork checked against it before printing.

Serialisation and track-and-trace obligations now apply in a growing number of markets, requiring unique identifiers at pack and sometimes case level, aggregation data linking packs to cases and pallets, tamper-evident features, and data upload to a national repository within defined timeframes. Where your market imposes these, the manufacturer must be capable of meeting them, which is a facility capability question we resolve during manufacturer selection rather than after an order.

Pack presentation can be tailored within regulatory limits: blister or strip configurations, bottle counts and closure types, carton quantities, hospital and institutional packs, and physician sample packs where permitted. Any change to a registered presentation may require a regulatory variation, so we flag that consequence rather than treating a pack change as a simple commercial request.

Storage, cold chain and transport

Storage and transport conditions are part of the product specification. Most oral solids ship at controlled ambient temperature, but the definition of acceptable ambient conditions differs by market and many products carry a stated maximum temperature and humidity. Products requiring refrigeration or freezing need a validated cold chain end to end, and a break in that chain is a product loss rather than a delay.

Where a cold chain applies, we specify validated insulated packaging or reefer transport, temperature monitoring with data loggers whose records are supplied with the shipment, qualified packing configurations with defined hold times, and contingency planning for customs delay, which is the most common point of failure. We also confirm that the destination has the storage capability to receive the product, because a validated cold chain that ends at an unrefrigerated warehouse has achieved nothing.

For ambient shipments we still plan for the route rather than the nominal specification. A container crossing the tropics reaches internal temperatures well above ambient, so we specify insulated liners, temperature monitoring and, where the product warrants it, a different transport mode. Air freight is used where product value, shelf life or temperature sensitivity justifies the cost.

Transport documentation and handling are arranged as part of the export package: commercial invoice and packing list, certificate of origin, transport document, insurance, and any permit or authorisation the movement itself requires. Controlled substances and products subject to special import or export authorisation are a separate matter, and we will only proceed where the required authorisations are genuinely in place on both sides.

What we will and will not do

Being clear about limits protects both sides in this category. We will identify and vet licensed manufacturers, verify their approvals, obtain and coordinate manufacturer-side documentation, negotiate commercial terms, manage production follow-up and inspection, arrange compliant packing, labelling verification and transport, and issue the export documentation set. We will tell you honestly when a requirement is not achievable at a stated price or timeline.

We will not advise on the clinical selection, substitution, use or dosing of any medicine. We will not represent that a product is safe or effective for any purpose. We will not supply into a market where the importer does not hold the required licences, and we will not supply a product that is not permitted in the destination market. We will not present an unlicensed or uncertified manufacturer as an approved one, and we will not proceed on documentation we have not been able to verify.

We also decline enquiries that carry obvious regulatory or ethical problems: requests to ship prescription medicines to unlicensed buyers or private individuals, requests to mislabel or misdeclare goods, requests to route product to avoid a registration requirement, and requests involving products subject to controls that the buyer cannot evidence authorisation for. Declining these is not commercial caution; it is the condition of operating in this category at all.

Starting a generic pharmaceutical enquiry

Send us the product details: molecule or brand reference, strength, dosage form, pack presentation, and the quantity per order and per year. Then tell us the destination market, whether you hold a current import licence, whether the product is already registered there, and if not, whether you intend to register it. If you have a target price or a competing offer, sharing it lets us tell you quickly whether it is realistic from a licensed, properly documented source.

We will come back with a feasibility assessment, an indication of which kind of manufacturer suits the requirement and what approvals they hold, an indicative price and lead time, the documentation package available, and an honest view of the regulatory pathway and its timeline. Where the requirement cannot be met compliantly, we will say so at that stage rather than after you have committed.

First projects in this category are best structured deliberately: confirm the manufacturer and documentation, complete registration where required, then run a modest first order against the approved specification before scaling. It takes longer than a commodity purchase, and in a regulated category that sequence is the difference between a supply relationship that lasts and a consignment stopped at the border.