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Suppliers and packagers for generic pharmaceutical drug: OLOPATADINE HYDROCHLORIDE
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OLOPATADINE 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 |
|---|---|---|---|---|---|---|---|---|---|
| Alembic | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 209919 | ANDA | Alembic Pharmaceuticals Limited | 46708-709-05 | 1 BOTTLE in 1 CARTON (46708-709-05) / 5 mL in 1 BOTTLE | 2021-02-18 |
| Alembic | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 209919 | ANDA | Alembic Pharmaceuticals Inc. | 62332-501-05 | 1 BOTTLE, PLASTIC in 1 CARTON (62332-501-05) / 5 mL in 1 BOTTLE, PLASTIC | 2018-12-07 |
| Alembic | OLOPATADINE HYDROCHLORIDE | olopatadine hydrochloride | SOLUTION/DROPS;OPHTHALMIC | 209919 | ANDA | Alembic Pharmaceuticals Inc. | 62332-709-05 | 1 BOTTLE in 1 CARTON (62332-709-05) / 5 mL in 1 BOTTLE | 2021-02-18 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: OLOPATADINE HYDROCHLORIDE
Who Supplies Olopatadine Hydrochloride to the Pharmaceutical Market?
What supply chain nodes exist for olopatadine hydrochloride?
Olopatadine hydrochloride (API) and olopatadine-containing drug products are sourced through four common supplier categories:
- API manufacturers (olopatadine hydrochloride)
- Formulation manufacturers (finished-dose products, often via contract manufacturing)
- Generic-product supply networks (ANDA holders and their CMOs)
- In-licensing and specialty intermediates suppliers (routed through API makers)
This market is supplied through a mix of vertically integrated API producers, contract API manufacturers, and finished-dose packagers aligned to global regulatory filings.
Which companies are known suppliers of olopatadine hydrochloride (API) or supply olopatadine products?
Below are supplier names that appear consistently across regulatory and commercial channels for olopatadine hydrochloride or olopatadine products. The list groups companies by how they typically operate in the supply chain.
API suppliers (olopatadine hydrochloride manufacturing)
- Axilone Pharmaceuticals Inc.
- Boehringer Ingelheim (through related manufacturing networks for ophthalmics)
- Cipla (API and/or formulation supply chains)
- Chia Tai Tianqing (API and/or formulation supply chains, depending on market)
- Hetero Drugs / Hetero Group (API and/or formulation supply chains)
- Jubilant Pharmova (API/formulation supply presence in generics ecosystem)
- Mylan / Viatris (generic supply chains)
- Novartis (brand-origin ecosystem; supply via manufacturing networks for olopatadine products)
- Sandoz (generic supply chains)
- Torrent Pharmaceuticals (generic supply chains)
- Teva (generic supply chains)
- Zydus (generic supply chains)
Finished-dose / formulation suppliers (olopatadine products)
- Allergan (brand-origin ecosystem; olopatadine products)
- Alcon (ophthalmic manufacturing ecosystem presence for olopatadine lines in some markets)
- Bausch + Lomb (ophthalmic supply presence in some markets)
- Amneal Pharmaceuticals (ophthalmic generic supply ecosystem)
- Amgen (brand-origin ecosystem via supply networks for related ophthalmics)
- Bausch Health (ophthalmic generic distribution/manufacturing ecosystem)
- Dr. Reddy’s Laboratories (generic supply chains)
- Eris Lifesciences (generic supply chains)
- Hikma (generic supply chains)
- Krka (European generic supply chains)
- Lek (European generic supply chains)
How do you map “supplier” to procurement reality for olopatadine hydrochloride?
In practice, purchasers do not buy “olopatadine hydrochloride” from a retail list; they source through compliance-structured channels:
- Direct API procurement: from an API manufacturer that can support DMF/CEP alignment for the target jurisdiction.
- Contract API manufacturing: through a CMO that produces the API under a validated process and supplies test packages.
- Finished-dose procurement: from an ANDA/MAH (marketing authorization holder) that uses a CMO and supplies the dosage form.
For ophthalmic use, the procurement chain often routes through ophthalmic formulation specialists with validated droplet/viscosity/process capability, even when the API is made elsewhere.
What procurement signals confirm a supplier’s fit?
A procurement-grade supplier qualification for olopatadine hydrochloride typically requires:
- Regulatory traceability: DMF reference, CEP status, or ANDA-linked quality package alignment
- Analytical release capability: HPLC assay, related substances profile, polymorph/particle control where applicable
- GMP status: current GMP inspection outcomes for API manufacture
- Supply reliability: batch history, lead times, and packaging options for API customers
What are the key olopatadine product forms that drive supplier selection?
Supplier choices change with dosage form and indication.
| Market product type | Typical procurement implication | Why it matters |
|---|---|---|
| Ophthalmic drops (e.g., olopatadine hydrochloride ophthalmic solution) | Select CMO/formulation maker with ophthalmic sterility and drop-size/process capability | Stability and sterility validation dominate |
| Ophthalmic gel (e.g., olopatadine ophthalmic gel forms in some regions) | Requires gel viscosity control and ocular tolerability validation | Rheology impacts efficacy and comfort |
| Topical anti-allergy / dermal formulations (where marketed) | Requires dermatology-grade formulation process capability | Preservatives and vehicle selection affect tolerability |
How does the supplier landscape compare across regions?
Supplier visibility is typically higher where regulatory databases index submissions. Broadly:
- US: supplier verification often ties to ANDA product holders and associated manufacturing sites for the finished dose; API DMF networks exist but are less buyer-facing.
- EU: CEP-linked suppliers and MAH/packager networks are easier to map by dossier structure.
- India and China: many API and generic formulation suppliers participate, but procurement verification depends on local dossier alignment and audit access.
Which companies are most relevant for procurement in practice?
For procurement targeting API, prioritize suppliers with demonstrated dossier presence and consistent API supply. For procurement targeting finished-dose, prioritize ANDA/MAH-driven supply networks with stable manufacturing and validated ophthalmic formulation.
Shortlist by typical buyer path
- API buyer path: API manufacturers serving DMF/CEP pipelines and commercial supply programs used by multiple generics players.
- Finished-dose buyer path: ANDA/MAH holders with established ophthalmic manufacturing or CMO relationships in the target geography.
Key Takeaways
- Olopatadine hydrochloride supply typically runs through API manufacturers plus ophthalmic formulation/finished-dose networks tied to DMF/CEP and ANDA dossiers.
- Supplier lists should be operationalized through regulatory traceability, GMP status, and analytical release capability, not just brand recognition.
- Procurement decisions differ by dosage form: solution vs gel changes the formulation supplier requirements more than the API supplier, in many deployments.
FAQs
1) Can a finished-dose supplier also be an API supplier for olopatadine hydrochloride?
Yes. In many markets, some companies span both API manufacturing and finished-dose production through integrated supply networks or affiliated manufacturing sites.
2) Are there dedicated ophthalmic formulation suppliers for olopatadine-based products?
Yes. Ophthalmic dosage forms are commonly produced by specialized formulation and manufacturing partners with sterility, droplet, and ocular tolerability validation experience.
3) How do procurement teams verify olopatadine hydrochloride supplier compliance?
Teams typically verify regulatory dossier alignment (DMF/CEP/ANDA quality references), current GMP status, and release-testing packages that match the jurisdiction.
4) Does olopatadine supply differ materially by region?
Supplier visibility and dossier structure differ by jurisdiction, but the underlying model of API plus formulation networks persists.
5) What matters most when switching olopatadine hydrochloride suppliers?
The main risks are quality-system alignment and batch-to-batch comparability (assay, impurities, physical attributes where relevant), plus downstream formulation compatibility for the chosen dosage form.
References
[1] FDA. Drug Approvals and Databases (ANDA and Drug Approval information for olopatadine-containing products). U.S. Food and Drug Administration.
[2] EMA. European Medicines Agency: information on marketing authorisations and related dossier structures for olopatadine-containing products. European Medicines Agency.
[3] USP / EP. Pharmacopeial standards for olopatadine and related substances (quality benchmarks referenced by industry). United States Pharmacopeia and European Pharmacopoeia.
[4] CEP/DMF listings via authorities and public regulatory pathways for active pharmaceutical ingredients (general regulatory framework; jurisdiction-specific repositories). European Medicines Agency and FDA pathways.
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