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Suppliers and packagers for generic pharmaceutical drug: ORPHENADRINE CITRATE
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ORPHENADRINE CITRATE
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hikma | ORPHENADRINE CITRATE | orphenadrine citrate | INJECTABLE;INJECTION | 040463 | ANDA | Hikma Pharmaceuticals USA Inc. | 0641-6182-25 | 25 BOX in 1 BOX (0641-6182-25) / 10 VIAL in 1 BOX (0641-6182-10) / 2 mL in 1 VIAL (0641-6182-01) | 2003-04-28 |
| Sagent Pharms | ORPHENADRINE CITRATE | orphenadrine citrate | INJECTABLE;INJECTION | 090585 | ANDA | Sagent Pharmaceuticals | 25021-651-02 | 10 VIAL in 1 CARTON (25021-651-02) / 2 mL in 1 VIAL | 2011-10-01 |
| Watson Labs | ORPHENADRINE CITRATE | orphenadrine citrate | INJECTABLE;INJECTION | 084779 | ANDA | Actavis Pharma, Inc. | 0591-3222-47 | 10 AMPULE in 1 CARTON (0591-3222-47) / 2 mL in 1 AMPULE (0591-3222-02) | 2010-07-08 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for generic pharmaceutical drug: ORPHENADRINE CITRATE
Orphenadrine Citrate Suppliers: Who Manufactures API and Bulk Drug Product?
Orphenadrine citrate supply is concentrated in a small set of international API manufacturers, with additional distribution handled by branded- and generic-drug supply chains. Orphenadrine citrate is used in oral formulations and is typically sourced either as API (orphenadrine citrate salt form) or as finished-dose product through distributor networks.
Bottom line: For procurement planning, separate sourcing into (1) orphenadrine citrate API and (2) finished oral dosage forms (generics and private-label), then map each option to the relevant quality dossier pathway (DMF/CEP where applicable), lead times, and regulatory documentation used by your target market.
Who supplies orphenadrine citrate API and what is the supply chain structure?
Orphenadrine citrate is supplied through two main channels:
-
API manufacturers (orphenadrine citrate salt)
- Provide active ingredient for formulators and finished-dose manufacturers.
- Documentation typically includes DMF support (letter of authorization where needed) or equivalent quality packages depending on jurisdiction.
-
Finished-dose manufacturers and authorized distributors
- Provide tablets and other oral forms through the drug supply chain.
- Often procure API from one or a small number of upstream sources, then manage regulatory compliance at the product level.
Procurement implication: If your goal is formulation or manufacturing, prioritize API supplier capability (salt form control, polymorph/hydrate behavior where relevant, impurity profile, and consistent residual solvents). If your goal is market availability, prioritize finished-dose supply reliability, packaging formats, and regulatory status in the target country.
Which companies are known suppliers of orphenadrine citrate API?
A complete, names-included supplier list cannot be produced from the information available here.
What finished-dose suppliers provide orphenadrine citrate tablets (US and EU distribution)?
A complete, names-included list of finished-dose suppliers cannot be produced from the information available here.
How do US FDA regulatory listings affect who can supply orphenadrine citrate?
For the US market, practical supplier selection depends on whether the product appears in the FDA’s Orange Book and what filing type is listed (e.g., ANDA) plus any listed patents and exclusivity terms. For API sourcing, procurement typically depends on whether an API master file (DMF) or other approved quality documentation is accessible to the finished-dose applicant.
Key supplier filters for US procurement:
- Product-level regulatory status (Orange Book listing for finished dose)
- Whether the supplier supports regulatory filings through DMF access
- Batch release testing alignment (impurity thresholds, assay, dissolution specs where applicable)
- Ability to meet US cGMP expectations for the specific manufacturing sites supplying the dosage form
How do DMF access and CEP coverage determine API supplier eligibility?
API buyers typically require one of the following documentation routes:
- DMF-backed API quality for finished-dose filings, supported by letter-of-authorization structure
- CEP-based certification in jurisdictions that recognize it, supported by ongoing compliance
Operational supplier implications:
- Suppliers with stable DMF/CEP documentation can reduce regulatory friction and speed tech transfer.
- Suppliers without accessible quality dossiers tend to create longer onboarding timelines or require additional bridging work.
How many API suppliers exist for orphenadrine citrate, and what does that mean for pricing?
A quantified count of distinct approved or active API suppliers cannot be produced from the information available here. In general, a narrow supplier base can increase:
- Lead-time volatility
- Batch-to-batch variability risk
- Pricing pressure during capacity disruptions
What are the typical lead times, minimum order quantities, and packaging options?
Specific numeric lead times, MOQ, and packaging formats cannot be produced from the information available here.
What quality and compliance requirements should be used to qualify orphenadrine citrate suppliers?
For supplier qualification, buyers typically run a structured program that includes:
- Identity and salt-form confirmation
- Verification of orphenadrine citrate salt form, assay, and relevant characterization tests
- Impurity control
- Impurity profile aligned to internal specifications and any DMF/registered documentation
- Residual solvents and processing controls
- Evidence of solvent management and consistent manufacturing controls
- Stability and re-test policy
- Shelf-life and re-test dates justified by stability data
- GMP status and audit history
- Site compliance, batch traceability, deviations/CAPA maturity
- CoA and batch-release documentation
- CoA completeness, test methodology consistency, and documentation turnaround
- Packaging and handling
- Moisture protection and container integrity validation for salt forms
How does API-to-finished-dose tech transfer affect supplier choice?
If you plan to switch API suppliers or qualify a second source, the key technical gates typically include:
- Comparative impurity and assay acceptance testing
- Dissolution and performance bridging for the salt form in your formulation
- Stability verification after formulation and packaging changes
- Scale-up feasibility and process capability assessment
Commercial impact: Faster onboarding comes from suppliers with consistent impurity profiles and well-established DMF/CEP documentation.
What generic or branded competition affects orphenadrine citrate supply decisions?
A product-specific competitive and revenue exposure map cannot be produced from the information available here.
Key Takeaways
- Orphenadrine citrate sourcing splits into API supply and finished-dose supply.
- US eligibility is strongly influenced by Orange Book status for finished doses and DMF/quality dossier accessibility for APIs.
- Supplier qualification should focus on salt-form control, impurity profile, batch documentation, GMP compliance, and stability/re-test frameworks.
- A complete list of named API and finished-dose suppliers cannot be produced from the information available here.
FAQs
1) What documentation do finished-dose manufacturers typically require from an orphenadrine citrate API supplier?
DMF/quality dossier support or equivalent certifications, plus CoAs, impurity profile evidence, and batch traceability consistent with cGMP requirements.
2) Can orphenadrine citrate be supplied from multiple API sources without changing formulation performance?
It requires comparative testing for identity, impurity profile, and performance in the final dosage form, because salt form and impurity differences can affect release and stability.
3) What is the most practical way to de-risk an orphenadrine citrate supply interruption?
Qualify a second API source and maintain alternate finished-dose sourcing paths with verified documentation and release testing alignment.
4) Does CEP coverage replace DMF for US filings?
CEP alone does not substitute for US regulatory expectations for filings; DMF/quality access is typically required depending on the submission route.
5) What are the typical main drivers of supplier switching for older oral drugs like orphenadrine citrate?
Documentation access, consistent impurity control, reliable batch-to-batch supply, lead-time stability, and audit readiness.
References (APA)
No sources are cited because supplier/company lists and regulatory listing specifics were not provided in the prompt and cannot be generated without external reference material.
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