Help · 34 questions

Frequently asked questions

What people ask us most — whether you are holding a pack and want to know it is genuine, evaluating us as a supplier, or checking how the company operates.

Verifying a pack

Where do I find the verification code on my carton?: It is on the serialisation panel, in the human-readable line beneath the GS1 DataMatrix. On saleable cartons the code sits under a silver scratch panel — scratch it off to reveal it. Enter it at /verify exactly as printed; spaces and dashes are ignored, and the check is not case-sensitive.
What does the check at /verify actually confirm?: It confirms that the code belongs to a carton commissioned by Ergopharm, and returns the matching monograph, batch (LOT) and expiry. Compare those three against what is printed on the carton in your hand — they must agree. Verification confirms origin and identity; it cannot confirm how the pack was stored or handled after it left our packaging hall.
The code does not match — what should I do?: Do not use the product. First re-read the code carefully, as 0/O and 1/I are easily confused, and enter it again. If it still returns no match, treat the pack as unverified: retain it and its packaging, photograph the serialisation panel, LOT and expiry, and send the images with a note of where the pack was obtained to quality@ergopharm.net.
The code verifies, but the batch or expiry shown differs from what is printed on my carton.: That is a discrepancy and should be treated as seriously as a failed check — a genuine code can be copied onto a carton that is not ours. Quarantine the pack, do not use or dispense it, and report it to quality@ergopharm.net with photographs of the carton, the serialisation panel and the code. Please also tell whoever supplied you the pack.
The pack looks tampered with. What now?: Do not use it. Every outer carton leaves the line with an anti-tampering device applied and verified; a broken, resealed or missing seal, an already-scratched verification panel, or a carton that has been opened means the chain of custody cannot be assured. Keep the pack intact, photograph it, and report to quality@ergopharm.net — and, if the pack was dispensed to you, tell your pharmacist or prescriber and report to your national medicines authority.
Can I just scan the DataMatrix with my phone?: The mark is a GS1 DataMatrix (ECC200) encoding four Application Identifiers: GTIN (01), expiry (17), batch (10) and serial (21). A GS1-capable scanner will parse those fields, but general-purpose phone apps frequently mis-read the FNC1 header and separators and show a garbled string. For a person holding a pack, the human-readable line plus /verify is the reliable route.
Does checking a code use it up, or can I check more than once?: The check at /verify is read-only — it does not decommission the pack, and you may check as often as you wish. Decommissioning happens in-market at the point of dispense, in territories that operate a national repository. Repeated checks of the same code are normal and are not treated as suspicious.

Ordering & distribution

Can I buy directly from Ergopharm as an individual?: No. Every product in the register is prescription-only and is supplied to licensed pharmaceutical distributors and importers only. Ergopharm operates no consumer shop, takes no personal orders and ships nothing to private addresses. If you need one of these medicines, it must come through a prescriber and a licensed pharmacy in your own market.
What does "For Export Only" on the carton mean?: It means the pack was manufactured at our Vadodara facility for supply outside the domestic Indian market, under the prescription rules of the importing country. It is a statement about the intended supply route, not about quality or grade — the product is made, tested and released to the same standard regardless of destination. Packs marked this way are not for domestic sale or distribution in India.
How does a distributor start working with Ergopharm?: The route is set out under "Become a Distributor" on /export: enquiry and mutual NDA, verification of your wholesale distribution or import authorisation, KYC and GDP due diligence, product and dossier alignment, then a supply agreement and first serialised consignment. Open the enquiry via /contact or export@ergopharm.net. We do not quote or ship before licence verification is complete.
What information will you ask us for?: Your wholesale distribution or import licence for prescription medicines, the destination market and expected volumes, the regulatory and documentation requirements of that market, and your preferred Incoterms. The full enquiry checklist is on /contact. Sending these with the first message shortens onboarding considerably.
Which Incoterms and transport conditions do you offer?: We work to Incoterms 2020 and offer EXW, FCA, CIP, DAP and DDP. Consignments ship ambient below 25 °C or, where required, 2–8 °C in qualified shippers, with calibrated data loggers on the load. Distribution follows the EU GDP Guidelines (2013/C 343/01), and any temperature excursion detected on receipt triggers quarantine and formal assessment before disposition.
Why is a product available in one country but not another?: Availability is decided by national registration, not by our capacity. Each market requires its own marketing authorisation and import permissions, held and filed by the local partner with that country's authority; until that is granted we cannot supply there. Pack artwork, language and serialisation requirements also differ per market, so the register at /products reflects what we manufacture, not what is on sale in any given country.
What pack formats are available?: The register runs to 27 prescription-only monographs: 13 ampoule presentations, each "10 Ampoules × 1 ml" in USP Type I amber or transparent glass, and 14 tablet presentations supplied as blister or bulk fills of 50 or 100 tablets per carton. Every saleable carton — injectable or oral — is serialised and carries its own DataMatrix and verification code. Full pack details sit on each datasheet under /products.

Quality, manufacturing & documentation

How is the product actually made?: Two streams feed one serialised packaging hall. Injectables are sterile-filtered through a 0.22 µm membrane and filled under Grade A first-air protection against a Grade B background, into ampoules under a nitrogen blanket; oral solids run a granulation, compression and coating train in classified areas. Cleanroom grades A–D, environmental monitoring, gowning and line clearance are described in full on /manufacturing.
What testing is done before a batch is released?: Each batch is tested against its finished-product specification using validated analytical methods (ICH Q2(R2)): identification, assay, uniformity of dosage units (USP <905>), dissolution or disintegration (USP <711>/<701>) and related substances (ICH Q3B), with sterility (USP <71>), bacterial endotoxins (USP <85>) and particulate matter (USP <788>) added for injectables. Any out-of-specification result is investigated before a disposition decision is taken. The full release panel is on /quality.
How are expiry dates established?: Shelf life is supported by stability studies run to ICH Q1A(R2) — long-term at 25 °C/60% RH, intermediate at 30 °C/65% RH and accelerated at 40 °C/75% RH, covering climatic zones I–IVb. The expiry printed on the carton is the period supported for the labelled storage conditions. Product should not be used beyond it, and stability data for a given monograph is available to partners on request.
What documentation can a partner obtain?: Certificate of Analysis per batch, a WHO Certificate of a Pharmaceutical Product (CoPP), a GMP certificate covering facility conformance, stability data per product, artwork and serialisation data per consignment, and dossier support in ICH CTD format (Modules 1–5). These are released to qualified partners under agreement — request them through quality@ergopharm.net or the Documentation Requests tab on /export.
Do you hold approval from a specific national regulator?: We do not claim approval by any named authority, and you should be sceptical of any supplier who does so loosely. What we describe are our own processes and packaging, referenced against published standards: GMP, ICH Q1/Q2/Q3/Q7–Q10, USP and Ph. Eur., GS1, and the EU GDP guidelines. Marketing authorisation in a destination market is filed and held by the local partner with that country's authority; our role is to supply the CoPP and the dossier that supports the filing.
How is traceability and data integrity maintained?: Records are kept to ALCOA+ principles — attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available. Every carton's LOT and expiry trace back to a complete batch manufacturing record, and deviations, OOS investigations, CAPA and change control are tracked to closure with periodic Product Quality Reviews. Release is authorised only against the reviewed batch record.
What happens if a quality defect or recall arises?: Report it to quality@ergopharm.net with the product, strength, LOT and expiry, and quarantine the stock rather than returning or destroying it unilaterally. We investigate against the batch record, the in-line serial reconciliation and the release data. Because packs are aggregated to case and pallet (SGTIN to SSCC, recorded as EPCIS events), a batch can be traced to the consignments and cases it went to, which is what makes a targeted recall possible.

Products, prescribing & safety

Can Ergopharm advise me on whether to take a product, or on my dose?: No, and we will decline if asked. Ergopharm is a manufacturer, not a clinical service; dose, interval and suitability are determined by the prescriber who knows the patient. Our medical information desk, medinfo@ergopharm.net, answers factual questions about composition, storage, presentation and product characteristics — it does not diagnose, recommend, adjust treatment or supply product.
Are all your products prescription-only?: Yes. All 27 monographs are prescription-only medicines intended for use under medical supervision, and the cartons carry the Rx ONLY mark. They are not consumer products and must not be used without a prescription and clinical oversight. Contraindications and warnings for each monograph are set out on its datasheet under /products.
How do I report a suspected side effect?: Write to pv@ergopharm.net with the product name and strength, the LOT and expiry from the carton, a description of the event and its dates, and whether you are the patient or a healthcare professional. Please also report to the prescriber and to your country's national adverse-event reporting system — contacting us does not replace national reporting, and the national route is what feeds regulatory safety surveillance. Pharmacovigilance obligations are coordinated with our partner in each market.
Where does the information on each product datasheet come from?: Each datasheet mirrors the carton and its Summary of Product Characteristics: composition, indications, dosage, contraindications, storage and warnings, alongside the serialisation data. It is product information written for healthcare professionals and distributors, not patient instructions. Where the datasheet and the leaflet supplied inside the pack differ in a market, the leaflet approved for that market governs.
How should packs be stored?: Ampoules: store below 25 °C, protect from light, do not freeze, and keep them in the outer carton until use. Tablets: store below 25 °C in a dry place, in the outer carton. If a pack has been left outside those conditions, do not use it — set it aside and ask your pharmacist, or, for a consignment, follow the excursion procedure described on /manufacturing.
Several products carry a sport-related warning — what does that mean?: A number of monographs contain substances prohibited in sport under the WADA Prohibited List, and the warnings field on those datasheets says so. Holding a valid prescription does not by itself permit use in competition; athletes should consult their national anti-doping organisation, including on the therapeutic use exemption process. We state the fact on the pack and the datasheet and take no further position on individual cases.
Someone is offering Ergopharm product on a marketplace or social media. Is it genuine?: We supply licensed distributors and importers only, and we list nothing for sale on marketplaces, messaging apps or social media. A pack offered outside the licensed chain has no verifiable chain of custody, even if its code happens to verify — a copied code on a repackaged carton is exactly the failure mode serialisation exists to expose. Please report such offers to quality@ergopharm.net with a link and screenshots.

About Ergopharm

Who is Ergopharm and where do you manufacture?: Ergopharm Advanced Research Centre manufactures prescription medicines for export from Tandalja, Vadodara, Gujarat 390012, India. The site runs two streams — sterile injectable ampoules and oral solids — with cartoning and serialisation performed in-house rather than subcontracted. The company history and milestones are on /about.
What is serialisation and why does Ergopharm build the brand around it?: Serialisation gives each carton a unique identity: a GS1 DataMatrix (ECC200) encoding GTIN (01), expiry (17), batch (10) and a random serial (21), which together form an SGTIN, plus a human-readable serial line. Packs are aggregated to case and pallet under SSCC (00) and recorded as EPCIS events, so a carton can be placed in its consignment. It is what allows a distributor, pharmacist or patient to confirm origin independently — see /serialisation.
Do your packs meet EU FMD and US DSCSA requirements?: The packs are built to the standards those frameworks rely on: a 2D DataMatrix carrying a unique identifier together with an anti-tampering device, as specified by Directive 2011/62/EU and Regulation (EU) 2016/161, and package-level aggregation with EPCIS event data of the kind DSCSA enhanced tracing requires. Repository upload and decommissioning at the point of dispense are performed in-market by the authorisation holder or partner, not by us. We describe the standards our packaging follows and do not assert market-specific compliance status on their behalf.
Are the facility figures on the site specific to a certified site?: The cleanroom classifications, particle and microbial limits and airflow figures follow published classification vocabulary — WHO TRS 961 Annex 6, aligned with EU GMP Annex 1 — and are illustrative of the facility standard. They are not a substitute for a site certificate, and we do not present them as one. Facility documentation, including the GMP certificate, is provided to qualified partners under agreement.
Which address should I write to?: info@ergopharm.net for general enquiries; export@ergopharm.net for markets, distributor onboarding and pricing; quality@ergopharm.net for CoA, CoPP, GMP certificate, dossier and quality defects; pv@ergopharm.net for suspected adverse events; medinfo@ergopharm.net for factual product questions. All five, with the enquiry checklist, are listed on /contact. Routing your message correctly at the outset is faster than a general enquiry that has to be forwarded.
Where are company and register updates published?: On /newsroom, which carries register changes, quality and serialisation notices, facility and capacity updates, and standards-alignment announcements, each with a full article. New or withdrawn monographs appear there and are reflected automatically in the register at /products. If you are a partner, material changes affecting your market are also communicated directly.

Not answered here

Medical information for healthcare professionals goes to medinfo@ergopharm.net. A suspected adverse reaction or quality defect goes to pv@ergopharm.net.