Adalat LA, sold in the US as Procardia XL, is a dihydropyridine calcium channel blocker licensed for hypertension and chronic stable angina in prolonged-release form, and FDA and MHRA-approved generic nifedipine tablets are available alongside the originator brand.
Adalat LA and Procardia XL are the brand names buyers still search for, though M Care Exports supplies nifedipine as a merchant exporter: we source the originator brand and FDA and MHRA-approved generic nifedipine tablets through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Nifedipine exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes nifedipine tablets against buyer specification: brand (Adalat LA/Procardia XL) or generic, prolonged-release strength mix (10 mg, 30 mg, 60 mg) and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because immediate-release nifedipine capsules carry documented risks in acute blood-pressure lowering and prolonged-release nifedipine tablets must never be split or crushed, we confirm the buyer's intended formulation and indication before dispatch, then align CTD/eCTD or country-specific dossier paperwork to the destination 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.
Dihydropyridine calcium channel blocker, sourced and documented for export.
Nifedipine is a dihydropyridine calcium channel blocker that inhibits calcium influx into vascular smooth muscle, causing coronary and peripheral vasodilation without a direct effect on cardiac conduction. It is dosed orally, not injected, and needs no reconstitution. The FDA label's flagship indications are hypertension, to reduce cardiovascular risk including stroke and myocardial infarction, and chronic stable or vasospastic (Prinzmetal) angina; UK SmPC labelling for Adalat LA covers the same hypertension and chronic stable angina indications. Immediate-release nifedipine capsules exist but are not licensed, and are specifically warned against, for acute blood-pressure reduction; tender specifications should default to a prolonged-release formulation unless the buyer confirms otherwise. Adalat LA/Procardia XL is supplied as prolonged-release or extended-release tablets, taken once daily and swallowed whole, never chewed, split or crushed.
Active ingredient
Nifedipine. Dihydropyridine calcium channel blocker.
Forms and strengths
10 mg immediate-release capsule; 30 mg prolonged-release tablet; 60 mg prolonged-release tablet; 90 mg extended-release tablet.
Indications
Nifedipine, a dihydropyridine calcium channel blocker indicated for hypertension and chronic stable or vasospastic angina in prolonged-release form, with a separate immediate-release 10 mg formulation used for preterm labour under WHO Essential Medicines List guidance. Supplied as originator Adalat LA/Procardia XL and licensed generic tablets from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Oral. Prolonged-release / extended-release tablet.
Documentation
Batch-specific CoA, CoPP, manufacturing-site WHO-GMP certificate and stability data compiled per consignment, in the format the destination regulator expects.
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 nifedipine are mainly hospital cardiology outpatient pharmacies managing hypertension and chronic stable angina, national and regional MoH tender desks running cardiovascular and NCD formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or maternal-health procurement programmes sourcing the immediate-release 10 mg formulation for preterm-labour indications where destination-country labelling permits that use.
GCC registration routes
Supply against MoH registration held by your local licensed importer, or via the GCC central registration pathway.
UK unlicensed routes
Where no UK licence exists, the MHRA Specials and named-patient import routes cover clinically justified demand.
Tender desks
Bid-pack documentation assembled to the tender's specification, from CoPP to batch records.
Dossier support
CTD documentation from the sourcing manufacturer, compiled for your regulator's format.
What the dispensing pharmacist checks on nifedipine.
Nifedipine's formulation matters more than most oral cardiovascular drugs: prolonged-release Adalat LA-type tablets are titrated from 20 mg or 30 mg once daily to a maximum 90 mg once daily for hypertension, while immediate-release capsules should not be dispensed for chronic hypertension or acute blood-pressure lowering at all, a distinction that has generated documented cases of hypotension when short-acting nifedipine was used inappropriately. Prolonged-release tablets must be swallowed whole; splitting, chewing or crushing disrupts the release matrix and risks a dose dump. Grapefruit juice significantly increases nifedipine plasma levels and should be flagged on any dispensing record. Nifedipine is contraindicated in cardiogenic shock, significant aortic stenosis and unstable angina, and UK labelling adds gastrointestinal stricture or Crohn's disease as contraindications to the prolonged-release tablet shell. It is excreted in breast milk in small amounts and animal data show embryotoxicity, so use in pregnancy is restricted to when clinically essential. No cold-chain handling is required.
The documentation pack a regulator actually asks for.
As an oral solid dosage form, nifedipine travels on standard ambient-temperature logistics rather than the cold-chain lanes M Care validates for biologics and insulins; UK SmPC labelling specifies storage below 30 degrees C, protected from light, and Procardia XL's US labelling specifies below 86 degrees F (30 degrees C) protected from moisture. 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. Nifedipine sits on the WHO Model List of Essential Medicines for a narrower set of uses than its licensing suggests: the current EML entry covers preterm labour (10 mg immediate-release, added 2005) and antihypertensive use (10 mg tablets and sustained-release formulations), after nifedipine was added in 1987 for both angina and hypertension, then removed from the angina listing in 1993 and from the essential-hypertension listing in 2005, so tender desks specifying nifedipine against the EML should confirm which indication and formulation the current listing supports rather than assume blanket coverage. On the brand-versus-generic question, Adalat LA (UK/EU) and Procardia XL (US) remain the originator products; FDA and MHRA-approved generic nifedipine tablets from multiple manufacturers are separately registered in the US, UK and EU, so buyers genuinely have a brand-or-generic choice, provided the generic matches the specific release profile (immediate, prolonged or extended) the tender calls for.
Buyers new to sourcing from India usually read the licensed import route explainer first, then the product page.
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.
Adjacent lines procurement desks order alongside nifedipine.
Molecule · strength · volume · destination. One working day to a quote.
- Send us the specifics. Form and strength, pack preference, destination market and indicative volume for nifedipine.
- We route to the right line. The enquiry goes to the WHO-GMP certified manufacturing partner whose certificates fit your regulator.
- Commercial and regulatory offer. FOB or CIF price with the documentation list, named manufacturing site and current certificate validity.
- Order, produce, release, ship. QC release on the Indian side, batch documents compiled, despatch on the agreed incoterm.
- After delivery. Batch records and certificates archived and retrievable for the life of the product on your shelf.
Nifedipine supply, the specific questions.
Does a generic version of Adalat LA/Procardia XL exist?
Yes. FDA and MHRA-approved generic nifedipine tablets are registered and marketed in the US, UK and EU alongside the originator brands Adalat LA and Procardia XL. Generic release profiles (immediate, prolonged or extended-release) vary by manufacturer, so M Care confirms the exact formulation against your tender before quoting brand or generic.
Can M Care supply Adalat LA or Procardia XL to our market?
Yes, on an import basis. We source the originator brand through licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
What strengths of nifedipine tablets are available?
Prolonged-release and extended-release tablets from 10 mg up to 90 mg, matching the Adalat LA and Procardia XL strength ranges. Tell us your indication, hypertension or chronic stable angina, and titration protocol and we quote the strength split accordingly.
Why does the release profile of nifedipine matter for a tender?
Immediate-release nifedipine capsules are not licensed for chronic hypertension or acute blood-pressure lowering and carry documented risk of marked hypotension when used that way. Prolonged-release or extended-release tablets are the licensed formulation for ongoing hypertension and angina management, so a tender specification should name the release profile explicitly, not just the molecule.
Is nifedipine safe in pregnancy?
Use is restricted to when clinically essential. Animal data show embryotoxicity and teratogenicity, and nifedipine is excreted in breast milk in small amounts. It also appears on the WHO Essential Medicines List for preterm labour management as an immediate-release 10 mg formulation, a distinct obstetric use from its cardiovascular licensing, so the intended indication should be confirmed before dispensing.
What documentation does M Care provide with a nifedipine shipment?
Batch-level certificate of analysis, CDSCO export documentation from the Indian side, and CTD/eCTD-aligned dossier support where the destination regulator requires local registration. Because prolonged-release tablets must not be split or crushed, we also confirm pack-insert wording matches destination-language labelling requirements before dispatch.
Who stands behind this page, and where its statements come from.
Reviewed by Dr. Rajat Bhatt, PharmD, Managing Director, M Care Exports. Last reviewed 2026-09-14.
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.
Send the specifics. You'll have a price inside one working day.
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.