Share This Page
Suppliers and packagers for LEVOCETIRIZINE HYDROCHLORIDE
✉ Email this page to a colleague
LEVOCETIRIZINE HYDROCHLORIDE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hetero Labs Ltd Iii | LEVOCETIRIZINE HYDROCHLORIDE | levocetirizine dihydrochloride | SOLUTION;ORAL | 210914 | ANDA | Camber Pharmaceuticals, Inc. | 31722-659-31 | 1 BOTTLE in 1 CARTON (31722-659-31) / 148 mL in 1 BOTTLE | 2019-04-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Levocetirizine Hydrochloride: API and Key Inputs
Which companies supply levocetirizine hydrochloride (API) and close intermediates?
Levocetirizine hydrochloride is produced by multiple large generics and fine-chemical manufacturers that also supply the chiral API market. Supplier landscapes typically split into: (1) API manufacturers (levocetirizine HCl) and (2) chemical intermediates and chiral synthesis inputs (pivotal for cost and timeline).
API suppliers (levocetirizine hydrochloride) and supply footprint The industry standard catalog view lists the following supplier types as core go-to sources:
| Supplier type | What they supply | Why they matter for sourcing |
|---|---|---|
| Global generics/API houses | Levocetirizine hydrochloride API | Scaled production, established regulatory dossiers in multiple markets |
| Specialty fine-chemical manufacturers | Chiral intermediates used to make levocetirizine | Timeline and cost leverage from intermediate availability |
| Contract manufacturers (CDMOs) | Finished dosage (tablets/syrup) using sourced API | Faster market entry if your program needs packaging and batch records, not only API |
| Regional wholesalers | API in branded trade packaging | Short lead time and continuity planning |
Who are the named API manufacturers most commonly referenced in levocetirizine supply chains?
A non-exhaustive set of commonly listed API producers and distributors for levocetirizine hydrochloride typically includes manufacturers in India and China, plus multi-market intermediates suppliers. However, listing specific company names and “supplies with proof” requires primary sourcing evidence (regulatory listings, distributor certificates, or catalog pages) that is not provided here.
What categories of intermediates control levocetirizine API availability?
Levocetirizine synthesis depends on controlled access to chiral building blocks and protected intermediates. In procurement practice, buyers focus on these supply-control categories:
- Chiral intermediate manufacturing capability (enantiopurity and batch-to-batch control)
- Salt formation and solid-state control (conversion to hydrochloride salt with defined specs)
- Impurity management (process impurities and enantiomeric impurity control)
- Regulatory documentation readiness (DMF/EDMF where applicable, CoA and test method alignment)
How should buyers qualify levocetirizine hydrochloride suppliers in procurement?
For levocetirizine hydrochloride, qualification is operationally driven by batch compliance, impurity profile, and documentation. The buyer’s qualification file typically must cover:
| Qualification element | What procurement should verify |
|---|---|
| Release specs | Identity, assay, water/solvent residues, and impurity limits |
| Enantiomeric purity | Enantiomeric impurity testing aligned to your target specification |
| Residual solvents | Compliance with ICH Q3C limits for the chosen process |
| Impurity panel | Process-related impurities and defined thresholds |
| Analytical methods | Method transferability to your QC lab |
| Regulatory status | Suitability for intended market filings (CEP/DMF/EDMF when used) |
| Supply continuity | Minimum order quantities, forecastability, change control history |
What sourcing paths exist (API vs dosage CDMO) for levocetirizine programs?
Levocetirizine programs typically choose one of two procurement architectures:
API-first route (common for generic marketers)
- Source levocetirizine hydrochloride API from an established producer
- Use a local or global formulation manufacturer for tablet or syrup
- Control risk by qualifying 1 primary + 1 secondary API supplier
CDMO route (common for faster product execution)
- Source API from the CDMO’s approved network
- CDMO handles formulation, filling, and packaging
- Contracts usually include API sourcing control and change notification clauses
What procurement metrics matter most for levocetirizine hydrochloride?
Buyers typically evaluate suppliers on the same business levers:
- Lead time from order to shipment (and whether it is stable across quarters)
- Batch sizes and MOQ (affects inventory and working capital)
- Documentation cadence (CoA turnaround and method alignment)
- Change control robustness (process or site changes without destabilizing impurity profile)
- Yield consistency for chiral synthesis inputs (impacts cost)
Key decision points for selecting among suppliers
When comparing suppliers for levocetirizine hydrochloride, procurement and R&D teams focus on:
-
Regulatory readiness
Ability to support filings in your target jurisdictions via accepted documentation formats. -
Quality system maturity
Consistent impurity control and repeatable assay across production campaigns. -
Supply resilience
Chiral intermediates and salt conversion capacity determine continuity. -
Commercial structure
Pricing model, MOQ, and lead time terms aligned to your launch plan.
Key Takeaways
- Levocetirizine hydrochloride sourcing hinges on chiral intermediate capability, impurity control, and regulatory documentation readiness, not only API availability.
- Supplier qualification should center on assay/identity, enantiomeric purity, residual solvents, impurity panel, and analytical method alignment.
- For execution, most programs run either an API-first model (dual-source API + local formulation) or a CDMO model (network-approved API with integrated manufacturing and batch records).
FAQs
1) What is the difference between suppliers for levocetirizine API and those for finished dosage?
API suppliers provide levocetirizine hydrochloride bulk drug substance. Dosage suppliers/CDMOs produce tablets/syrup using an approved API source under formulation and packaging manufacturing controls.
2) Why does enantiomeric purity matter for levocetirizine hydrochloride suppliers?
Levocetirizine is the active enantiomer. Suppliers must demonstrate control over enantiomeric impurity to meet pharmacopoeial and internal product specifications.
3) What documentation should be requested before placing a long-term order?
Procurement should require supplier CoAs, specification sheets, residual solvent and impurity panels, and (where applicable) DMF/EDMF or equivalent regulatory support aligned to target markets.
4) What production step most affects supply continuity for levocetirizine?
The chiral synthesis route and availability of key chiral intermediates, plus salt formation consistency, typically drive continuity and cost.
5) How do buyers reduce risk in levocetirizine hydrochloride supply?
Qualification of at least two approved sources (primary and secondary) plus monitoring change controls and impurity trends reduces operational risk.
References (APA)
[1] U.S. Food and Drug Administration. (n.d.). Drug approvals and related regulatory information (search portal). FDA. https://www.fda.gov/
[2] European Medicines Agency. (n.d.). EPARs and related information for medicinal products (search portal). EMA. https://www.ema.europa.eu/
[3] World Health Organization. (n.d.). WHO medicines and quality resources. WHO. https://www.who.int/teams/regulation-prequalification/medicines-quality-assurance-and-standards/quality-assurance
[4] International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. (2003). ICH Q3C: Impurities: Residual solvents. ICH. https://database.ich.org/
More… ↓
