Tygacil (tigecycline) is a Reserve-group glycylcycline antibacterial for complicated skin, soft-tissue and intra-abdominal infections where first-line antibiotics have failed, and FDA-approved generic tigecycline vials are available alongside the originator brand.
Tygacil (tigecycline), originated by Wyeth and now marketed by Pfizer, is a glycylcycline antibacterial dosed by intravenous infusion for infections where usual first-line antibiotics are not suitable. M Care Exports is a merchant exporter: we source the Pfizer brand and FDA and MHRA-approved generic tigecycline vials through licensed Indian distribution and manufacturing channels and dispatch on quote, not from our own manufacturing.
Tigecycline exporter and bulk supplier from India.
For hospital, wholesaler and tender-desk orders, M Care quotes tigecycline vials against buyer specification: brand (Tygacil) or generic, pack volume and destination-market regulatory documentation, drawn from licensed WHO-GMP manufacturer lines on the M Care roster. Because tigecycline sits in the WHO AWaRe Reserve group and carries a boxed mortality warning, we confirm the buyer's stewardship or infectious-disease sign-off pathway 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.
Glycylcycline antibacterial (tetracycline-class derivative); 30S ribosomal protein synthesis inhibitor, sourced and documented for export.
Tigecycline is a glycylcycline antibacterial, structurally derived from the tetracycline class, that inhibits bacterial protein synthesis by binding the 30S ribosomal subunit; its glycylcycline side chain lets it evade the efflux-pump and ribosomal-protection resistance mechanisms that defeat older tetracyclines, which is why it retains activity against many multidrug-resistant Gram-positive and Gram-negative pathogens. It is dosed only by intravenous infusion, never orally. The FDA and MHRA/EMA labels licence it for complicated skin and soft-tissue infections and complicated intra-abdominal infections; the US label also carries community-acquired bacterial pneumonia, and it is explicitly not indicated for diabetic foot infections or for hospital-acquired or ventilator-associated pneumonia. Tygacil is supplied as a 50 mg lyophilised powder in a single-dose 10 mL vial, reconstituted before infusion.
Active ingredient
Tigecycline. Glycylcycline antibacterial (tetracycline-class derivative); 30S ribosomal protein synthesis inhibitor.
Forms and strengths
50 mg lyophilised powder, single-dose vial.
Indications
Tigecycline, a glycylcycline antibacterial indicated for complicated skin and soft-tissue infections and complicated intra-abdominal infections, classified in the WHO AWaRe Reserve group for use where alternative antibiotics are unsuitable. Supplied as originator Tygacil and licensed generic vials from Indian WHO-GMP facilities to regulated and semi-regulated markets outside India.
Administration
Intravenous. Lyophilised powder for solution for infusion.
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 tigecycline are mainly hospital infectious-disease and ICU pharmacists managing suspected or confirmed multidrug-resistant infections, antimicrobial-stewardship committees that track Reserve-group consumption, national and regional MoH tender desks running critical-care or AMR-response formulary lists, licensed pharmaceutical wholesalers and importers, and NGO or foundation procurement programmes supporting drug-resistant infection response 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.
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 tigecycline.
Tigecycline is dosed at a 100 mg loading dose followed by 50 mg every 12 hours by IV infusion over 30 to 60 minutes, for 5 to 14 days depending on infection site and severity; no renal adjustment is needed, but severe hepatic impairment (Child-Pugh C) cuts the maintenance dose to 25 mg every 12 hours after the same 100 mg load. Reconstitute each vial with 5.3 mL of sodium chloride 0.9%, dextrose 5% or Lactated Ringer's to 10 mg/mL, then dilute the required dose into a 100 mL infusion bag to a maximum concentration of 1 mg/mL before administration. Reconstituted solution is stable for 24 hours at room temperature or 48 hours refrigerated, and unreconstituted vials need no cold-chain handling, just protection from excursions above 30°C. Tigecycline carries a boxed warning for higher all-cause mortality versus comparator antibiotics in pooled trial data, so prescribers should reserve it for situations where alternative agents are unsuitable and document that rationale, which is also the basis for its WHO AWaRe Reserve classification.
The documentation pack a regulator actually asks for.
As a lyophilised powder for reconstitution, tigecycline travels on standard ambient-temperature logistics rather than the validated cold-chain lanes M Care runs for biologics and insulins, provided storage stays within the labelled 20 to 25°C range with permitted excursions. What buyers need instead is batch-level certificate of analysis, CDSCO export documentation and, where the destination regulator requires local registration, CTD or eCTD-format dossier support. Tigecycline sits in the WHO AWaRe Reserve group, the category of last-resort antibiotics tracked for antimicrobial-resistance stewardship reporting, but it is not currently on the WHO Model List of Essential Medicines: it was added in 2017 and removed again in 2019, so tender desks building an AMR-response formulary should treat it as a stewardship-committee-approved addition rather than an automatic EML-listed stock item. On the brand-versus-generic question, Tygacil remains the Pfizer originator product; FDA-approved generic tigecycline for injection is separately registered in the US from multiple manufacturers, and MHRA-licensed generic tigecycline 50 mg vials are also registered in the UK, so buyers genuinely have a brand-or-generic choice once destination-market registration is confirmed.
The paperwork above is the molecule-specific part; the general pathway a destination regulator expects is set out in our licensed import route guide.
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 tigecycline.
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 tigecycline.
- 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.
Tigecycline supply, the specific questions.
Does a generic version of Tygacil exist?
Yes. FDA-approved generic tigecycline for injection is registered in the US from multiple manufacturers, and MHRA-licensed generic tigecycline 50 mg vials are separately registered in the UK alongside the originator brand Tygacil. Registration status for generic tigecycline varies by destination country, so M Care checks local approval before quoting brand or generic against a specific tender.
Can M Care supply Tygacil to our market?
Yes, on an import basis. We source Tygacil through Pfizer's licensed Indian distribution channels and dispatch against your import authorisation and any local registration your pharmacy, hospital or wholesaler holds.
What strength does tigecycline come in?
Tigecycline is supplied as a 50 mg lyophilised powder in a single-dose 10 mL vial, reconstituted to 10 mg/mL before further dilution for infusion. It is not available as an oral tablet or capsule; intravenous infusion is the only licensed route.
Why would a hospital reserve tigecycline rather than use it first-line?
Tigecycline sits in the WHO AWaRe Reserve group of last-resort antibiotics and carries an FDA boxed warning for higher all-cause mortality versus comparator antibiotics in pooled trial data. Labelling states it should be used only where alternative treatments are not suitable, which is also why many antimicrobial-stewardship committees require documented justification before it is dispensed.
Is tigecycline on the WHO Essential Medicines List?
No, not currently. It was added to the WHO Model List of Essential Medicines in 2017 under the Reserve-group antibiotics section, then removed in 2019. It remains classified under the separate WHO AWaRe Reserve category used for antimicrobial-resistance stewardship tracking, so buyers should treat it as a formulary-specific addition rather than an EML-listed stock item when building a tender specification.
What documentation does M Care provide with a tigecycline 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 tigecycline is a Reserve-group antibiotic, we can also confirm the sourcing partner's batch release paperwork ahead of a stewardship-committee or tender-desk review, on request.
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.