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Suppliers and packagers for NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
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NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Altaire Pharms Inc | NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE | naphazoline hydrochloride; pheniramine maleate | SOLUTION/DROPS;OPHTHALMIC | 078208 | ANDA | Altaire Pharmaceuticals Inc. | 59390-177-13 | 15 mL in 1 BOTTLE, DROPPER (59390-177-13) | 2010-10-06 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
Who Supplies Naphazoline Hydrochloride and Pheniramine Maleate for Pharmaceutical Use?
What are the commercially relevant supplier categories for these APIs?
Supplies for Naphazoline Hydrochloride and Pheniramine Maleate typically flow through four procurement channels, each with distinct documentation and quality expectations:
| Supplier channel | What it supplies | Typical buyer use case |
|---|---|---|
| API manufacturers | Active pharmaceutical ingredient (API) in bulk | Commercial API procurement, contract manufacturing input |
| API importers/distributors | API sourced from an upstream maker, sold under own distribution controls | Faster sourcing, reduced qualification burden vs direct maker |
| Contract manufacturers (CDMOs) | Finished intermediates and finished dosage forms, plus API as needed | Outsourced development and manufacturing |
| Specialty chemical suppliers | Lab/technical grade and sometimes pharma-grade via documentation | Early formulation work, method development, limited QA expectations |
For either API, buyers generally need: CEP/DMF (if available), CoA, GMP certificate for the manufacturing site, and product-specific impurity specs aligned to the intended market.
Which suppliers manufacture or distribute Naphazoline Hydrochloride (API)?
The supplier universe for Naphazoline Hydrochloride is dominated by API manufacturers in Asia and Europe, plus distributors that carry pharma-grade inventory. Procurement lists typically include:
- API manufacturers producing naphazoline hydrochloride under cGMP/HEP (where applicable) with export documentation
- Pharma distributors that sell under a controlled distribution model and can supply CoA batches on request
However, no verifiable supplier roster can be stated from the information provided. A complete, accurate “supplier list” requires sourcing the names from authoritative registries (for example, drug master files, CEP certificate holders, or FDA/EMA facility listings) or from authenticated procurement databases. This request does not include any registry snapshot, geography, grade (pharma vs technical), or documentation constraints, so enumerating specific company names would be incomplete or potentially incorrect.
Which suppliers manufacture or distribute Pheniramine Maleate (API)?
Pheniramine Maleate has a similarly structured supply chain: multiple API makers worldwide and a parallel layer of distributors and contract manufacturing networks.
- API manufacturers supplying pharma-grade bulk material
- Distributors sourcing from one or more upstream manufacturers and providing batch-level documentation
As with naphazoline hydrochloride, a complete and accurate supplier list cannot be produced from the provided input.
What procurement documentation typically distinguishes pharma-grade API supply from technical-grade supply?
Buyers usually screen supplier quality using the following artifacts and controls:
| Documentation item | Why it matters |
|---|---|
| GMP certificate for API site | Confirms regulated manufacturing environment |
| CEP (EDQM) or DMF reference | Demonstrates regulatory dossier alignment |
| CoA with batch-specific impurity profile | Validates specification compliance |
| Transport and handling controls | Minimizes degradation and mix-ups |
| Analytical methods and impurity list | Ensures reproducible quality and regulatory defensibility |
Even where supplier names are available, these artifacts determine whether the material can enter a controlled pharmaceutical manufacturing chain.
What finished product context matters for these APIs?
These APIs commonly appear in combination ophthalmic or decongestant formulations (depending on market), and that context affects which supplier routes are used:
- Ophthalmic / nasal decongestant formulations often require tighter impurity and particle specs at the API and finished product level.
- Combination products increase traceability requirements because APIs must match the finished formulation pathway used by the MAH.
That means not all “API suppliers” qualify equally for the buyer’s intended dosage form and market authorization strategy.
Key Takeaways
- Supply for Naphazoline Hydrochloride and Pheniramine Maleate typically comes from API manufacturers and pharma-grade distributors, with CDMOs involved when the buyer outsources formulation and manufacturing.
- A specific named supplier roster cannot be produced accurately from the provided input because it requires authoritative source confirmation (GMP/CEP/DMF or verified procurement databases).
- Procurement readiness depends more on documentation and spec alignment (GMP certificate, CEP/DMF, CoA, impurity profile) than on marketing claims.
FAQs
-
Are naphazoline hydrochloride and pheniramine maleate sold as APIs only, or also as intermediates?
They are primarily procured as APIs for drug manufacture; some supply chains also involve intermediate synthesis for internal production by API makers. -
Do CDMOs always source these APIs, or can they require the MAH to supply them?
CDMOs typically can supply APIs if qualified, but many contracts allow or require customer-supplied APIs under agreed quality agreements. -
What is the most important qualification document for API suppliers?
A current GMP certificate for the specific manufacturing site is the gating item in most pharma procurement frameworks. -
Can a distributor be used instead of an API manufacturer directly?
Yes, when the distributor can provide full batch traceability, CoA, and confirm the upstream manufacturing site’s regulatory status. -
Does intended dosage form change API supplier requirements?
Yes. Ophthalmic or other sensitive dosage forms often drive stricter impurity, particle, and control strategy requirements.
References
[1] European Directorate for the Quality of Medicines & HealthCare (EDQM). European Certificates of Suitability (CEPs) database.
[2] FDA. Drug Master Files (DMF) database and related guidance (FDA access and listing pages).
[3] EMA. EudraGMDP and related GMP inspection and manufacturer information resources.
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