Suppliers and packagers for generic pharmaceutical drug: levocetirizine dihydrochloride

levocetirizine dihydrochloride

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Chartwell Molecular	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	SOLUTION;ORAL	204599	ANDA	Chartwell RX, LLC	62135-917-38	148 mL in 1 BOTTLE (62135-917-38)	2017-05-15
Padagis Us	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	SOLUTION;ORAL	091263	ANDA	Padagis Israel Pharmaceuticals Ltd	45802-680-28	148 mL in 1 BOTTLE (45802-680-28)	2011-11-07
Padagis Us	LEVOCETIRIZINE DIHYDROCHLORIDE	levocetirizine dihydrochloride	SOLUTION;ORAL	091263	ANDA	Bryant Ranch Prepack	63629-2533-1	1 BOTTLE in 1 CARTON (63629-2533-1) / 148 mL in 1 BOTTLE	2011-11-07

Suppliers and packagers for generic pharmaceutical drug: levocetirizine dihydrochloride

Last updated: May 26, 2026

Levocetirizine Dihydrochloride suppliers: WHO makes it, where is it sourced, and how to qualify manufacturers

Levocetirizine dihydrochloride (active ingredient) is supplied globally by multiple API manufacturers and is also produced by contract manufacturers that support finished-dose brands and generic supply chains. Supplier selection for levocetirizine APIs typically hinges on DMF/CEP availability, regulatory inspection history, particle-size and polymorph control, and ability to supply consistent impurity profiles under ICH Q3A/Q3B and Q7 GMP.

Who are the main levocetirizine dihydrochloride API suppliers globally?

Levocetirizine API sourcing is concentrated in established small-molecule API hubs in India and China, with second-tier suppliers in Europe and other regions depending on customer demand (US/EU dossiers, NDA/ANDA filing needs, and commercial contract manufacturing requirements). The most common supplier categories seen in commercial supply chains:

API manufacturers (levocetirizine dihydrochloride bulk powder)

• Sell levocetirizine dihydrochloride as API for generic and branded solid oral dosage forms (tablets, capsules, and oral solution/syrup).
• Common qualification requirements include DMF reference number(s) for US filings and GMP certificates for EU/ROW audits.

Intermediates and outsourcing partners

• Provide key intermediates or finish-step outsourcing (crystallization, salt formation to dihydrochloride, milling/particle control).
• Often the API manufacturer and its intermediate suppliers appear in customer qualification audits even if the intermediate is not sold directly to the finished-dose label holder.

Finished-dose CDMOs

• Support manufacturing of finished levocetirizine products using customer-supplied API or co-sourced API.
• Useful when the objective is to reduce regulatory/CMC risk and shorten product transfer.

What levocetirizine dihydrochloride suppliers sell through US DMFs and ANDA dossiers?

US ANDA filers and branded CMO customers typically prefer API suppliers with:

• an active Drug Master File (DMF) on file (API manufacturing site and controls),
• a consistent impurity profile and validated test methods,
• a history of FDA inspections or acceptable EIR outcomes,
• supply capacity that matches batch frequency for annual and seasonal demand.

Supplier lists in practice are driven by which API sites already support ANDA filers. Many levocetirizine API customers source through networks where the API DMF is already referenced by multiple ANDA submissions, reducing CMC transfer burden.

How to find levocetirizine dihydrochloride suppliers for finished-dose manufacturing (tablets, capsules, oral solution)?

Finished-dose manufacturing adds constraints beyond API availability:

• formulation compatibility with levocetirizine dihydrochloride salt properties,
• water content and hygroscopicity control for wet granulation or direct compression,
• particle-size distribution and flow properties for uniform content,
• container-closure compatibility for oral liquids.

CDMO qualification checklist for levocetirizine

• Experience with antihistamine solid oral dosage forms and/or oral liquids
• Ability to manage impurity control in the drug substance and carry through to finished product specs
• Documented process validation approach for scale-up and tech transfer
• Stability program aligned to label storage claims

Which manufacturers dominate the levocetirizine API supply chain in India and China?

Levocetirizine dihydrochloride is widely produced by the same cluster of suppliers that supply multiple second-generation antihistamine APIs. In commercial procurement, the dominance pattern follows:

• India: high-volume API and intermediate producers with multi-site capacity and frequent DMF-backed supply
• China: scale-oriented API production with large-scale batch manufacturing and price competitiveness

Procurement decisions usually separate suppliers into:

• “filing-ready” DMF-backed API vendors
• “commercial-ready” vendors focused on supply continuity and pricing

How many levocetirizine dihydrochloride API suppliers are typically qualified per label holder?

Most branded manufacturers and large generic label holders keep a dual-source or multi-source strategy:

• 2 qualified API suppliers minimum for continuity during inspections, raw material shortages, or site-specific deviations
• 1 backup supplier either partially qualified (limited testing) or qualified for a subset of grade/particle-size ranges

The objective is to prevent supply interruption while managing CMC transfer scope.

What quality documents and certifications do levocetirizine dihydrochloride suppliers provide?

Common supplier documentation requested in qualification:

• GMP certificate(s) for the API manufacturing site(s)
• CoA (Certificate of Analysis) with full impurity panel and method references
• specification sheet covering strength, identity, impurity limits, residual solvents, and water content
• validation summary for analytical methods used for impurity and assay testing
• change control policy and notification timeline for process or site changes

How does levocetirizine dihydrochloride salt form affect supplier testing requirements?

Because the API is a dihydrochloride salt, buyers typically focus on:

• salt identity confirmation (polymorph and form control where relevant)
• crystallization consistency (batch-to-batch reproducibility)
• stability under humidity and temperature (particularly for oral liquid formulations)
• impurity generation pathways from manufacturing route and solvent system choice

What formulation types drive levocetirizine dihydrochloride supplier requirements?

Supplier suitability changes by dosage form:

• Tablets/capsules: prioritize powder flow, compressibility, and impurity control
• Oral solution/syrup: prioritize hygroscopicity and stability profile, plus packaging compatibility
• Pediatric dosage strengths: prioritize uniformity and consistent release profile

What are the key procurement risks in levocetirizine dihydrochloride sourcing?

Risk areas seen in supply chain reviews:

• single-site dependency when a preferred supplier’s capacity is constrained
• batch impurity excursions due to input raw material variability
• delays in DMF updates or post-approval CMC reporting for process changes
• compliance risk when a site is under inspection or has a recent compliance action

Mitigation is typically handled via:

• supplier audits and periodic requalification
• qualification of alternate input lots and route robustness
• strict incoming CoA review plus sampling plans

What supplier qualification timeline is realistic for levocetirizine dihydrochloride?

For API qualification supporting an ANDA or branded product change:

• initial lab evaluation: weeks
• stability and comparative impurity assessment: months
• tech transfer or process validation alignment (if switching sites): often a full campaign cycle
• regulatory reporting alignment: dependent on filing stage and post-approval change category

Procurement teams usually structure qualification to avoid switching during peak seasonal demand.

How does levocetirizine dihydrochloride supplier choice affect FDA and EU regulatory posture?

Regulatory posture is driven by:

• whether the API supplier site and process are already referenced or accepted under filed CMC
• inspection outcomes at the API manufacturing site
• change control performance and ability to document comparability

For EU, compliance is influenced by GMP status and variation management under the applicable regulatory framework.

What is the competitive landscape for levocetirizine supply (API vs finished-dose CDMOs)?

In practice:

• API supply is fragmented with many regional producers, but the “qualified for filing” set is smaller.
• finished-dose CDMOs concentrate on specific dosage forms and customer segments (branded relabelers vs ANDA generic manufacturers).

A label holder that prioritizes speed-to-market often chooses:

• an API supplier already referenced by multiple ANDAs, and
• a CDMO with an established process for levocetirizine tablet/capsule or oral liquid.

What to include in an RFP for levocetirizine dihydrochloride suppliers

For procurement that needs CMC-safe supply, the RFP typically requires:

• API site GMP status and certificate copies
• DMF or equivalent regulatory documentation (where applicable)
• full impurity panel history and typical ranges
• residual solvent profile and compliance statements
• polymorph/salt identity controls and characterization summary
• batch size, yield, and annual capacity
• change control notification commitments
• CoA format and method reference packages
• lead time and minimum order quantities

Key Takeaways

• Levocetirizine dihydrochloride API sourcing is concentrated among established small-molecule API manufacturers, with quality and regulatory readiness determining “qualified” supplier status.
• Buyers typically maintain at least two qualified API suppliers to manage inspection, capacity, and batch variability risks.
• Salt-form control, impurity consistency, and DMF-backed documentation are the main differentiators in supplier selection for US/EU submissions.
• CDMO selection for finished dosage forms depends on moisture and hygroscopicity handling plus formulation-specific powder and stability requirements.

FAQs

Which suppliers are best for filing-ready levocetirizine dihydrochloride (US DMF) supply?

Filing-ready suppliers are those with active DMF coverage for the API manufacturing site and a track record of batch impurity consistency aligned to ANDA CMC expectations.

Can levocetirizine dihydrochloride be sourced from multiple API grades for tablets and oral liquids?

Yes, but grade choice must match formulation needs, especially moisture management and impurity specs that carry through to finished product.

What supplier documentation is most important for levocetirizine dihydrochloride qualification?

GMP certificate(s), CoA with impurity panel, specification and method package, salt-form/identity controls, and change control policy are typically the deciding documents.

How do inspections affect levocetirizine dihydrochloride supply continuity?

Site-level inspection outcomes can trigger supply holds or CMC change reporting requirements, so multi-site qualification is a standard continuity approach.

What is the most common supplier structure for levocetirizine supply (API only vs API plus CDMO)?

Many customers use a separation model (API supplier plus CDMO) to keep CMC ownership clear and reduce dependency on a single integrated vendor.

References

1. United States Food and Drug Administration. (n.d.). Drug Master Files (DMF). https://www.fda.gov/drugs/development-approval-process-drugs/drug-master-files-dmfs
2. European Medicines Agency. (n.d.). GMP and inspections. https://www.ema.europa.eu/en/human-regulatory/research-development/good-manufacturing-practice-gmp/gmp-inspections
3. ICH Harmonised Tripartite Guideline. (2007). Q7: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients. https://ich.org/