WHO-GMP sourced EU-GMP partners ISO 9001:2015 49+ export markets Since 2003

Neurontin (gabapentin) is licensed in the US for postherpetic neuralgia and adjunctive partial-seizure therapy, and in the UK and EU for a broader peripheral neuropathic pain indication as well as epilepsy, with generic gabapentin capsules and tablets available worldwide alongside the originator brand.

Neurontin (gabapentin) is an oral anticonvulsant and neuropathic-pain agent structurally related to GABA but acting on the alpha-2-delta subunit of voltage-gated calcium channels. M Care Exports is a merchant exporter: we source the originator brand and generic gabapentin capsules, tablets and oral solution through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.

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WHO-GMP sourcing CDSCO licensed exporter EU-GMP capable partners Cold-chain validated (2–8°C & −25°C) CTD / eCTD dossier-ready ISO 9001:2015
Bulk supply and export terms

Gabapentin exporter and bulk supplier from India.

For hospital, wholesaler and tender-desk orders, M Care quotes gabapentin against buyer specification: brand (Neurontin) or generic, dosage form (capsule, tablet or oral solution), strength mix (100 mg, 300 mg, 400 mg capsules; 600 mg, 800 mg tablets) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because the UK licensed indication for peripheral neuropathic pain is broader than the US label's postherpetic-neuralgia-only wording, we confirm the buyer's destination-country labelling before finalising a quote, then align CTD/eCTD or country-specific dossier paperwork to the regulator's requirements.

Source

WHO-GMP-certified Indian manufacturing line, named on every quote.

Minimum order

No blanket MOQ. Set by the source manufacturer's minimum batch-release quantity for the strength and pack ordered.

Pricing

On request. Indicative FOB or CIF quote, formal proforma on confirmation.

Incoterms

EXW, FOB, CIF, CIP or DAP.

Payment

Letter of credit (sight or usance) and telegraphic transfer.

Documentation

WHO-GMP certificate of the source line, product-specific CoPP, batch CoA, method of analysis, Free Sale Certificate, Certificate of Origin, CTD or eCTD dossier. On request.

Shelf-life

Minimum remaining shelf-life agreed per order and confirmed on the proforma.

Response

Availability and CoPP status within two working days; pre-alert documents before dispatch.

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At a glance

Anticonvulsant / gabapentinoid, alpha-2-delta calcium channel subunit ligand, sourced and documented for export.

Gabapentin is an anticonvulsant and neuropathic-pain agent that binds the alpha-2-delta-1 subunit of voltage-gated calcium channels, reducing excitatory neurotransmitter release; despite the name, it does not act on GABA receptors. It is dosed orally, not injected, and needs no reconstitution. The FDA label's flagship indications are postherpetic neuralgia in adults and adjunctive therapy for partial-onset seizures in patients three years and older; UK and EU labelling additionally covers peripheral neuropathic pain in adults, including painful diabetic neuropathy, a wider licensed use than the US label carries. Neurontin is supplied as 100 mg, 300 mg and 400 mg capsules, 600 mg and 800 mg tablets, and a 250 mg/5 mL oral solution, with dosing individualised by indication and titrated from a low starting dose.

Active ingredient

Gabapentin. Anticonvulsant / gabapentinoid, alpha-2-delta calcium channel subunit ligand.

Forms and strengths

100 mg capsule; 300 mg capsule; 400 mg capsule; 600 mg film-coated tablet; 800 mg film-coated tablet; 250 mg/5mL oral solution.

Indications

Gabapentin, marketed as Neurontin, is an oral anticonvulsant and neuropathic-pain agent that binds the alpha-2-delta subunit of voltage-gated calcium channels. Supplied from Indian WHO-GMP facilities to regulated and semi-regulated markets, brand or generic, subject to destination-country controlled-substance scheduling.

Administration

Oral. Capsules, film-coated tablets and oral solution.

Documentation

Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.

Who we supply

Hospital pharmacies, licensed importers and tender desks across our export markets.

India is our origin. We do not sell into the Indian market.

Buyers for gabapentin are mainly hospital neurology and pain-management pharmacies managing epilepsy and neuropathic pain caseloads, national and regional MoH tender desks running anticonvulsant and chronic-pain formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting epilepsy-care access in markets where local registration is in place. Because several destination countries now schedule gabapentin as a controlled substance, buyers also include regulatory affairs teams managing import licensing for scheduled medicines.

GCC registration routes

Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.

MoH registration, GCC →

UK unlicensed routes

Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.

MHRA Specials →

Tender desks

Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.

Tender response →

Dossier support

CTD documentation from the sourcing manufacturer, compiled for your regulator's format.

Dossier preparation →

Pharmacist's note

What the dispensing pharmacist checks on gabapentin.

Gabapentin dosing is titrated, not fixed: the standard adult regimen starts at 300 mg once daily on day one, rising to 300 mg twice daily on day two and three times daily on day three, with maintenance doses commonly 900-3,600 mg/day split across three doses; renal impairment requires dose reduction because gabapentin is cleared almost entirely unchanged by the kidneys, so creatinine clearance should be checked before a tender pack-mix is finalised. The oral solution needs 2-8°C cold storage, unlike the capsules and tablets, which travel on standard ambient logistics, so mixed-format orders should be flagged for split shipping. Gabapentin carries an FDA warning for life-threatening respiratory depression when combined with opioids or other CNS depressants, particularly in patients with compromised respiratory function, and, like other anti-epileptic drugs, a class warning for emergence or worsening of suicidal thoughts and behaviour requiring monitoring. From April 2019 the UK reclassified gabapentin as a Schedule 3 controlled drug under the Misuse of Drugs Regulations 2001, following evidence of misuse and gabapentin-related deaths, and several other markets have since introduced similar prescription-monitoring controls, so import documentation should be checked against current destination-country scheduling before dispatch.

Regulatory & quality

The documentation pack a regulator actually asks for.

As an oral solid (and liquid) dosage form, gabapentin capsules and tablets travel on standard ambient-temperature logistics; only the oral solution needs the 2-8°C cold-chain lane M Care validates separately for temperature-sensitive lines. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination market requires it, CTD or eCTD-format dossier support so the buyer's own regulator can register the product. Gabapentin is not currently on the WHO Model List of Essential Medicines; WHO's core anticonvulsant list is built around agents including carbamazepine, phenobarbital, phenytoin and valproic acid, with gabapentin discussed by the Expert Committee only as a second-line option, so buyers should treat it as a formulary-specific rather than an EML first-line agent when building a tender specification. On the brand-versus-generic question, Neurontin remains the originator product, with current FDA prescribing information listing Viatris Specialty LLC as the labeler; FDA and MHRA-approved generic gabapentin capsules, tablets and oral solution from multiple manufacturers have been separately registered and widely available in the US, UK and EU since 2004, so buyers genuinely have a brand-or-generic choice. Because gabapentin is now a scheduled controlled substance in the UK and in a growing number of other jurisdictions, M Care confirms the current import-licensing and prescription-monitoring status of the destination market with the buyer before quoting, which we treat as a standing due-diligence step rather than a one-off check.

For the import route itself, step by step from import licence to customs release, see importing branded medicines from India: the licensed route.

CoA and MoA, per batch

Batch-specific certificate and method of analysis from the sourcing manufacturer's QC release.

CoPP, WHO-GMP, MFG licence

Certificate of pharmaceutical product and site GMP certification issued via CDSCO channels, naming the actual manufacturing site.

CTD Module 3

Chemistry, manufacturing and controls documentation available from the sourcing manufacturer for registration filings.

Pack insert, labels, artwork

Destination-language patient information and labelling to the local regulator's standard, locked before shipment.

Pharmacovigilance

A named PV contact arranged in the destination market where the registration requires one.

How the enquiry works

Molecule · strength · volume · destination. One working day to a quote.

  1. Send us the specifics. Form and strength, pack preference, destination market and indicative volume for gabapentin.
  2. We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
  3. Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
  4. Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
  5. After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Frequently asked

Gabapentin supply, the specific questions.

Does a generic version of Neurontin exist?

Yes. FDA and MHRA-approved generic gabapentin capsules, tablets and oral solution are registered and marketed in the US, UK and EU alongside the originator Neurontin brand, and have been available since 2004. M Care can quote either the branded product or generic gabapentin lines depending on the buyer's tender specification and destination-market registration status.

Why does the UK label for gabapentin cover more than the US label?

US prescribing information for Neurontin lists postherpetic neuralgia and adjunctive partial-seizure therapy as the flagship indications. UK and EU labelling for generic gabapentin additionally licenses the drug for peripheral neuropathic pain in adults, including painful diabetic neuropathy, a broader indication set than the US label carries. Buyers should specify the destination market so M Care can align the quoted product's labelling to what that regulator has actually approved.

Is gabapentin a controlled substance?

In the UK, gabapentin became a Schedule 3 controlled drug under the Misuse of Drugs Regulations 2001 from 1 April 2019, following evidence of misuse and gabapentin-related deaths. Scheduling and import-licensing requirements vary by destination country, so M Care confirms the current controlled-substance status and any prescription-monitoring rules for the buyer's market before a quote is finalised.

Is gabapentin on the WHO Essential Medicines List?

No. Gabapentin is not currently on the WHO Model List of Essential Medicines; WHO's core anticonvulsant list is built around agents including carbamazepine, phenobarbital, phenytoin and valproic acid, with gabapentin considered by the Expert Committee only as a second-line option. Buyers building a tender around WHO-listed anticonvulsants should treat gabapentin as a formulary-specific addition rather than an EML first-line agent.

Does gabapentin need cold-chain handling?

Gabapentin capsules and tablets are stored at room temperature and travel on standard ambient logistics. Only the 250 mg/5 mL oral solution requires 2-8°C refrigerated storage, so an order that mixes solid-dosage and liquid formats should be flagged for split shipping under M Care's temperature-controlled lane.

What warnings apply to gabapentin dosing?

Gabapentin carries an FDA warning for life-threatening or fatal respiratory depression when combined with opioids or other CNS depressants, especially in patients with compromised respiratory function, and a class warning shared by anti-epileptic drugs for emergence or worsening of suicidal thoughts and behaviour requiring clinical monitoring. Dosing is titrated over the first three days of therapy and reduced in patients with renal impairment, since gabapentin is cleared largely unchanged by the kidneys.

Sources and review

Who stands behind this page, and where its statements come from.

Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-19.

This page is sourcing information for licensed importers, hospital procurement and tender desks. It is not medical, pharmaceutical or prescribing advice, and it is not a substitute for the approved product information of the line on your order. See our full disclaimer.

Gabapentin enquiry

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Form and strength, destination market and indicative volume. The Mumbai desk replies within one working day, including when the honest answer is that the route is not viable yet.

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