Suppliers and packagers for generic pharmaceutical drug: PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Actavis Labs Fl Inc	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	204982	ANDA	Teva Pharmaceuticals, Inc.	0480-2299-56	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-2299-56)	2025-05-07
Actavis Labs Fl Inc	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	204982	ANDA	Teva Pharmaceuticals, Inc.	0480-3295-56	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3295-56)	2025-05-07
Actavis Labs Fl Inc	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	204982	ANDA	Teva Pharmaceuticals, Inc.	0480-3296-56	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3296-56)	2025-05-07
Actavis Labs Fl Inc	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	204982	ANDA	Teva Pharmaceuticals, Inc.	0480-3297-56	30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0480-3297-56)	2025-05-07
Dr Reddys Labs Sa	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	208175	ANDA	Dr.Reddys Laboratories Inc	43598-624-30	30 CAPSULE in 1 BOTTLE (43598-624-30)	2025-06-01
Dr Reddys Labs Sa	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	208175	ANDA	Dr.Reddys Laboratories Inc	43598-625-30	30 CAPSULE in 1 BOTTLE (43598-625-30)	2025-06-01
Dr Reddys Labs Sa	PHENTERMINE HYDROCHLORIDE AND TOPIRAMATE	phentermine hydrochloride; topiramate	CAPSULE, EXTENDED RELEASE;ORAL	208175	ANDA	Dr.Reddys Laboratories Inc	43598-626-30	30 CAPSULE in 1 BOTTLE (43598-626-30)	2025-06-01

Suppliers and packagers for generic pharmaceutical drug: PHENTERMINE HYDROCHLORIDE; TOPIRAMATE

Last updated: April 26, 2026

Who Supplies Phentermine Hydrochloride and Topiramate for Pharmaceutical Use?

What are the core API supply inputs for Phentermine Hydrochloride and Topiramate?

Phentermine hydrochloride and topiramate are typically sourced as finished APIs (active pharmaceutical ingredients) from established chemical and API manufacturers. For formulation, downstream manufacturers also qualify excipients, packaging, and analytical reference standards, but the supply question for both drugs centers on API vendors, quality systems, and regulatory standing.

The information below is limited to what can be stated with specificity from provided source material. No vendor list was supplied in the prompt, and no external company database or document set was provided. Under these constraints, listing specific suppliers would risk factual errors.

Which suppliers should be evaluated for API qualification?

For both drugs, qualify suppliers through a consistent due diligence stack:

Qualification dimension	Supplier evaluation target
Regulatory status	GMP compliance, inspection history, and filings support (API DMF/ASMF or equivalent dossier)
Quality system	Batch traceability, deviation and CAPA performance, OOS/OOT handling
Analytical package	Method validation status, impurity profile consistency, reference standards supply
Synthetic route and impurity control	Control of process-related impurities and residual solvents (where applicable)
Supply assurance	Capacity, lead time, multi-site manufacturing, and continuity plans
Change management	Notification and comparability protocol for route, equipment, or spec changes

What are typical commercial supply roles in the chain?

For each API, the market commonly splits into three roles:

• API manufacturer: Produces phentermine hydrochloride or topiramate API under GMP.
• API trader/distributor: Aggregates inventory and can offer short lead times, but still requires that the end manufacturer is qualified.
• Custom synthesis/contract manufacturer: Produces under client specifications; qualification hinges on dossier support and impurity control.

How do phentermine hydrochloride and topiramate supplier requirements differ in practice?

Supplier evaluation focuses on the same core quality criteria, but practical differences show up in impurity risk and dossier content:

Factor	Phentermine hydrochloride	Topiramate
Dossier/quality focus	Consistent impurity profile and salt form control	Consistent impurity profile, route change control, and analytical robustness
Formulation relevance	Salt form identity and stability	Polymorph/grade sensitivity (where applicable) and impurity control
Change risk	Process adjustments can move impurity patterns	Route or crystallization changes can shift impurity distribution

Key Takeaways

• The prompt does not include vendor names, regulatory listings, or source documents; naming specific suppliers would be inaccurate.
• API qualification for both phentermine hydrochloride and topiramate should be driven by GMP status, dossier support, impurity control, and change-management performance.
• Build the supplier list from qualified API manufacturers first, then use distributors only after confirming the underlying API site and dossier linkage.

FAQs

1) Are phentermine hydrochloride and topiramate supplied mainly as APIs or intermediates?
Mainly as APIs. Intermediates are generally used by formulation manufacturers only when they run internal synthesis or use tightly integrated contract manufacturing.

2) What is the fastest way to validate a supplier for API supply?
Demand dossier-backed proof (DMF/ASMF or equivalent), recent CoA history with impurity trends, and GMP inspection evidence for the actual manufacturing site.

3) Do distributors count as suppliers for API qualification?
Distributors can be procurement partners, but qualification should target the underlying API manufacturer and manufacturing site.

4) What spec elements matter most during supplier onboarding?
Identity, assay, impurity profile (including specified and unspecified impurities), residual solvents (where applicable), and salt form or grade control, plus method validation credibility.

5) How should firms handle route or process changes by an API supplier?
Require advance notice, comparability protocols, and updated stability/impurity justification tied to the client’s finished product and regulatory filings.

References

[1]