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

Dalacin (clindamycin), sold in the US as Cleocin, is a lincosamide antibiotic for serious anaerobic and Gram-positive infections, carrying a class-defining boxed warning for Clostridioides difficile colitis, with licensed generic clindamycin capsules and injection available alongside the Pfizer brand.

M Care Exports supplies Dalacin (clindamycin), marketed in the US as Cleocin and originated by Pfizer's Upjohn heritage business, a lincosamide antibiotic reserved for serious infections where narrower-spectrum agents are unsuitable. As a merchant exporter, M Care sources both the Pfizer brand and licensed generic clindamycin capsules and phosphate injection through Indian WHO-GMP manufacturing channels and dispatches against a buyer's own tender specification, not from our own production line.

Also marketed as Cleocin Hydrochloride, Cleocin Phosphate and Cleocin T.

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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

Clindamycin exporter and bulk supplier from India.

For hospital, wholesaler and MoH tender orders, M Care quotes clindamycin against buyer specification: capsule strength (75mg, 150mg, 300mg), phosphate injection concentration, and brand-or-generic preference, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because clindamycin's boxed warning covers Clostridioides difficile colitis and rapid IV administration carries its own cardiopulmonary risk, we confirm the receiving unit's infusion protocol and counselling materials at enquiry, 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.

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At a glance

Lincosamide antibacterial, sourced and documented for export.

Clindamycin is a lincosamide antibacterial that binds the 50S ribosomal subunit to block bacterial protein synthesis, giving it bacteriostatic-to-bactericidal activity against anaerobes, streptococci, pneumococci and many staphylococci, including some meticillin-resistant strains where local susceptibility supports its use. The FDA label for Cleocin HCl covers serious infections caused by susceptible anaerobic bacteria, plus serious infections due to susceptible streptococci, pneumococci and staphylococci, generally reserved for penicillin-allergic patients or where penicillin is inappropriate; the UK Dalacin C SmPC frames the same gram-positive and anaerobic pathogen coverage. Destination-country labelling should be checked against this before a tender quote is finalised. Clindamycin is dosed both orally and parenterally: hard capsules at 75mg, 150mg and 300mg (as clindamycin hydrochloride) and a phosphate solution for injection or infusion at 150mg/mL, filled into vials of varying volume for IV or IM use.

Active ingredient

Clindamycin hydrochloride (oral capsules); clindamycin phosphate (injection). Lincosamide antibacterial.

Forms and strengths

75 mg capsule; 150 mg capsule; 300 mg capsule; 150 mg/mL solution for injection or infusion.

Indications

Clindamycin is a lincosamide antibacterial for serious anaerobic and Gram-positive infections, carrying a boxed warning for Clostridioides difficile colitis. Supplied from Indian WHO-GMP facilities as both originator Dalacin/Cleocin and licensed generic lines, to regulated and semi-regulated markets.

Administration

Oral, Intravenous, Intramuscular. Hard capsule for oral use, and clindamycin phosphate solution for injection or infusion.

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 clindamycin are hospital surgical, orthopaedic and obstetric pharmacists managing anaerobic, bone-and-joint and skin/soft-tissue infections, national and regional MoH tender desks running anti-infective procurement lists, licensed pharmaceutical wholesalers and importers serving hospital surgical and A&E departments, and NGO or foundation procurement programmes supporting surgical antibiotic access in markets where local registration is in place.

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 clindamycin.

Capsules must be swallowed whole with a full glass of water, with the patient remaining upright for at least 30 minutes, because clindamycin capsules carry a specific risk of oesophagitis and oesophageal ulceration if they lodge in the oesophagus. On the parenteral side, undiluted rapid IV push is a genuine hazard: clindamycin phosphate must be diluted and infused no faster than around 30mg per minute, since rapid administration has been linked to cardiopulmonary arrest and hypotension. Renal impairment needs no dose adjustment; hepatic impairment prolongs the half-life modestly, so periodic liver-function review is sensible on extended courses. Both dosage forms store at controlled room temperature, no cold-chain handling required, which simplifies last-mile freight relative to the biologics and cytotoxics often co-listed on the same hospital tender.

Regulatory & quality

The documentation pack a regulator actually asks for.

As oral capsules and a room-temperature phosphate injection, clindamycin ships on standard ambient, GDP-compliant logistics rather than the validated cold-chain lanes M Care runs for biologics; the emc SmPC confirms a 60-month shelf life for Dalacin C capsules that must not be stored above 25C. Clindamycin sits in WHO's AWaRe Access group, the antibiotic tier WHO wants forming the bulk of a country's consumption, and the WHO Model List of Essential Medicines carries it as a second-choice agent for osteomyelitis and osteitis, alongside first-choice status for necrotising fasciitis in WHO's own AWaRe guidance; buyers running antimicrobial-stewardship formularies can cite that Access-group status directly in tender justification. On brand versus generic, Dalacin and Dalacin C remain Pfizer's originator products outside the US, with Cleocin the equivalent US brand; licensed generic clindamycin capsules and phosphate injection are widely registered from multiple manufacturers, so this is a genuine, freely substitutable brand-or-generic choice, unlike some narrower-index molecules on the M Care roster. Buyers should also note that clindamycin phosphate injection is currently listed as an active FDA drug shortage, a live example of why formulary desks keep a secondary export source on file. M Care does not manufacture clindamycin itself and holds no WHO-GMP or WHO-PQ certification in its own name; every batch we export carries its manufacturing partner's own certification.

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 clindamycin.
  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

Clindamycin supply, the specific questions.

Does a generic version of Dalacin or Cleocin exist?

Yes. Licensed generic clindamycin capsules and clindamycin phosphate injection are widely registered and manufactured, and are freely substitutable for the Pfizer brand in most markets, unlike some narrower-index antibiotics. M Care quotes brand or generic against your tender specification and checks destination-market registration before dispatch.

Why does clindamycin carry a boxed warning?

Clostridioides difficile-associated diarrhoea, including fatal colitis in severe cases, has been reported with nearly all antibacterial agents but is specifically boxed on the clindamycin label because treatment with antibacterial agents alters normal gut flora and allows C. difficile to overgrow. Both the FDA and UK labelling reserve clindamycin for serious infections where less toxic agents are unsuitable.

What strengths of clindamycin does M Care supply?

Hard capsules at 75mg, 150mg and 300mg (as clindamycin hydrochloride), and clindamycin phosphate solution for injection or infusion at 150mg/mL, filled to the vial volumes your tender specifies. Tell us your dosing protocol and route mix and we quote accordingly.

Is there a supply risk buyers should plan around?

Yes. Clindamycin phosphate injection is currently listed on the FDA's active drug shortage tracker. It is a live example of why hospital and tender desks keep a secondary export source confirmed on file rather than relying on a single supply line.

Does clindamycin need cold-chain shipping?

No. Both the capsule and the phosphate injection are stored at controlled room temperature, below 25C, and move on standard ambient, GDP-compliant logistics rather than the validated cold-chain lanes M Care runs for biologics and vaccines.

Is clindamycin on the WHO Essential Medicines List?

Yes. Clindamycin sits in WHO's AWaRe Access group, the antibiotic tier WHO recommends should make up the bulk of a country's antibiotic use, and is listed on the WHO Model List of Essential Medicines as a second-choice agent for osteomyelitis and osteitis.

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 2026-09-13.

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.

Clindamycin enquiry

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