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Suppliers and packagers for HYDROCORTISONE AND ACETIC ACID
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HYDROCORTISONE AND ACETIC ACID
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Cosette | HYDROCORTISONE AND ACETIC ACID | acetic acid, glacial; hydrocortisone | SOLUTION/DROPS;OTIC | 040609 | ANDA | Cosette Pharmaceuticals, Inc. | 0713-0849-09 | 1 BOTTLE in 1 CARTON (0713-0849-09) / 10 mL in 1 BOTTLE | 2024-02-01 |
| Taro | HYDROCORTISONE AND ACETIC ACID | acetic acid, glacial; hydrocortisone | SOLUTION/DROPS;OTIC | 088759 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-3007-1 | 1 BOTTLE in 1 CARTON (51672-3007-1) / 10 mL in 1 BOTTLE | 2005-04-28 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
HYDROCORTISONE AND ACETIC ACID: Supplier Landscape for Pharmaceutical Use
Which suppliers provide hydrocortisone and hydrocortisone formulations for pharma manufacture?
Hydrocortisone is typically sourced in two supply categories: active pharmaceutical ingredient (API) and finished pharmaceutical products or intermediates used to formulate topical and otic products.
Common hydrocortisone API suppliers (global)
| Supplier / Company | Typical supply mode | Where it fits in pharma supply chain |
|---|---|---|
| CordenPharma | API and custom manufacturing | API supply and development for steroid APIs |
| Sudarshan Chemical Industries | Specialty chemicals (incl. pharma intermediates) | Steroid intermediate supply where applicable |
| Luye Pharma | API/manufacturing | Active and intermediate manufacturing for pharma |
| Hi-Tech / regional steroid API manufacturers | API and intermediates | Cost-competitive steroid API sourcing in bulk |
Common hydrocortisone finished-formulation or contract manufacturing suppliers (global)
| Supplier / Company | Typical supply mode | Where it fits |
|---|---|---|
| Dr. Reddy’s (contract manufacturing ecosystem) | Formulation / manufacturing network | Sourcing through CMOs and partner networks |
| Hindustan Unilever-adjacent? | Not applicable | Excluded; not a dedicated pharma steroid manufacturer |
| Contract manufacturing organizations (CMOs) | Formulation, filling, packaging | For hydrocortisone topical/otic products |
Note on practicality: For hydrocortisone, the most decision-relevant supplier shortlist is the one aligned to your intended dosage form (topical cream/ointment vs otic suspension vs injectable) and regulatory pathway (reference vs ANDA vs local registration). API-only procurement usually has narrower supplier availability.
Which suppliers provide acetic acid suitable for pharmaceutical manufacturing?
Acetic acid is usually sourced as pharmaceutical-grade acetic acid (or as a reagent with appropriate grade and documentation) for formulation, pH adjustment, and solvent systems. Pharma procurement typically requires CoA, specification compliance, impurity profile control, and traceability.
Global pharma-grade acetic acid suppliers
| Supplier / Company | Typical product positioning | Typical pharma use |
|---|---|---|
| Brenntag | Chemical distributor and supply broker | Sources pharma-grade acetic acid through manufacturer network |
| Merck (Sigma-Aldrich) | Lab and specialty chemicals | Supplies acetic acid meeting common pharmacopeial specs for R&D and some commercial needs |
| Thermo Fisher Scientific | Chemical supply | R&D scale; sometimes industrial-grade supply via partners |
| TCI Chemicals | Specialty chemicals | R&D and smaller-scale pharma use |
| Distillers / bulk chemical manufacturers (via distributors) | Bulk acetic acid | Often routed through pharma distributors for documentation and grade control |
Procurement reality: For commercial pharma production, many buyers do not buy from the original producer directly. They buy via pharmaceutical chemical distributors that provide consolidated documentation and stable lead times.
How suppliers map to the specific combination “HYDROCORTISONE AND ACETIC ACID”
Hydrocortisone plus acetic acid most commonly appears in otic formulations (ear drops/suspensions) or related topical/otic contexts where acetic acid controls pH or acts in the formulation system.
Most relevant procurement paths
| Combination need | Most common procurement path | Supplier type |
|---|---|---|
| Hydrocortisone API + acetic acid reagent | Direct API procurement plus pharma-grade acetic acid | API suppliers + chemical distributors/manufacturers |
| Finished dosage form sourcing | Purchase finished drug product (if permitted) or contract manufacturing | Finished-product manufacturers or CMOs |
| Formulation development and scale-up | R&D-grade materials that transition to pharma-grade specifications | Specialty chemical suppliers + regulated CMOs |
Which supplier categories win for speed, documentation, and regulatory readiness?
| Goal | Best-fit supplier category | Why it wins |
|---|---|---|
| Stable commercial supply | Large API manufacturers and pharma distributors | Lower risk of documentation gaps and lead-time variability |
| Faster regulatory documentation | Pharma distributors of acetic acid | CoA consistency, grade alignment, and batch traceability |
| Lower formulation change risk | Suppliers that support compendial specs | Controls for common identity and purity requirements |
| Development scale availability | Sigma/Merck/TCI-type suppliers | Fast lead time for R&D transitions |
Regulatory and documentation expectations that drive supplier selection
Hydrocortisone (API)
Supplier qualification typically hinges on:
- GMP manufacturing site compliance
- Drug Master File (DMF) availability (if your regulatory strategy uses a DMF pathway)
- CoA batch-to-batch consistency
- Impurity profile controls consistent with the pharmacopeia/specification you target
Acetic acid
Key supplier qualification typically hinges on:
- Appropriate grade (pharmaceutical/spec)
- Identity and impurity limits
- CoA documentation including stability and handling
- Traceability and change notification discipline
Actionable supplier shortlist structure (for procurement teams)
Use this shortlist architecture so procurement can move quickly without rework:
1) Hydrocortisone API
- Prioritize GMP steroid API manufacturers with experience in regulated submissions.
- Build a list of 3 to 5 suppliers based on: DMF availability, CoA consistency history, ability to meet your internal specification, and lead-time stability.
2) Acetic acid
- Prioritize pharmaceutical chemical distributors that can supply pharma-grade acetic acid with consistent documentation.
- Build a list of 2 to 4 suppliers based on: grade availability, impurity profile control, and CoA traceability for each batch.
3) If a finished combo product is needed
- Move to CMOs or finished-dose manufacturers with otic/topical capabilities and demonstrated regulatory experience in your target markets.
Key Takeaways
- Hydrocortisone procurement is primarily an API-regulated supply problem, optimized by GMP capability and documentation readiness.
- Acetic acid procurement is primarily a grade and CoA traceability problem, where pharma distributors often reduce execution risk.
- The best supplier structure is a dual track: steroid API manufacturers for hydrocortisone and pharmaceutical chemical distributors for acetic acid.
- The supplier list that matters most is the one aligned to dosage form and regulatory pathway (otic vs topical vs injectable).
FAQs
1) Can acetic acid be sourced from bulk chemical producers for pharma use?
Usually only if supplied under pharmaceutical-grade specifications with complete documentation (CoA, impurity control, and traceability). For execution, distributors typically bridge the documentation gap.
2) Do hydrocortisone API suppliers provide DMFs?
Many major API manufacturers do. When DMF availability is part of your regulatory path, prioritize suppliers with a track record of DMF-based submissions.
3) What most often delays hydrocortisone supplier onboarding?
Batch-to-batch impurity and specification adherence, plus GMP documentation alignment and change control discipline.
4) What do otic formulations typically require from acetic acid suppliers?
Consistent spec-grade acetic acid with controlled impurities and reliable CoA documentation, since pH and formulation stability are sensitive to quality variation.
5) Should procurement buy both ingredients separately or as a combo package?
If you control manufacturing, buy hydrocortisone and acetic acid separately from qualified sources. If speed to market matters more than control, buy through CMO/finished-dose channels.
References
[1] Brenntag. (n.d.). Acetic acid product information. Brenntag.
[2] Merck. (n.d.). Acetic acid, pharmaceutical/ACS grade product listings and specifications. Merck/Sigma-Aldrich.
[3] CordenPharma. (n.d.). Capabilities and API manufacturing (steroid and complex API context). CordenPharma.
[4] Luye Pharma. (n.d.). Company manufacturing and API capabilities overview. Luye Pharma.
[5] TCI Chemicals. (n.d.). Acetic acid product listings. TCI.
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