Suppliers and packagers for PAMELOR

PAMELOR

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013	NDA	SpecGx LLC	0406-9910-03	30 CAPSULE in 1 BOTTLE (0406-9910-03)	1977-08-01
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013	NDA	SpecGx LLC	0406-9911-03	30 CAPSULE in 1 BOTTLE (0406-9911-03)	1977-08-01
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013	NDA	SpecGx LLC	0406-9912-03	30 CAPSULE in 1 BOTTLE (0406-9912-03)	1977-08-01
Specgx Llc	PAMELOR	nortriptyline hydrochloride	CAPSULE;ORAL	018013	NDA	SpecGx LLC	0406-9913-03	30 CAPSULE in 1 BOTTLE (0406-9913-03)	1977-08-01

Suppliers and packagers for PAMELOR

Last updated: June 6, 2026

Pamelor (nortriptyline) Suppliers: Who Manufactures It, What Brands and Generics Compete, and Where Supply Is Concentrated

Executive summary: Pamelor is the brand of nortriptyline hydrochloride, a systemically dosed oral tricyclic antidepressant. Supply is typically provided through (1) the originator’s own manufacturing network and (2) multiple generic manufacturers across FDA-labeled strengths and dosage forms. Because “Pamelor” is usually marketed as a brand and nortriptyline is widely generic, downstream “supplier” questions most often map to (a) FDA-listed manufacturers for the active ingredient and finished dosage form and (b) the companies holding ANDAs that can sell near-term product under generic labeling.

Who are the FDA-listed manufacturers (suppliers) of Pamelor nortriptyline?

Direct answer: Pamelor supply is sourced from the manufacturer(s) listed on the FDA label for Pamelor (nortriptyline HCl tablets/caps, depending on presentation). For generic nortriptyline, supply is from the ANDA sponsors and their contract manufacturing organizations that hold the FDA-approved manufacturing section for the marketed dosage form and strength.

What “supplier” means for Pamelor

• Finished-dosage manufacturer: The site(s) named in the FDA label/manufacturing section for the marketed product.
• ANDA sponsor: The company that holds the approval for a generic product and is responsible for product release and regulatory compliance (often with contract manufacturing).
• Importer/distributor roles: Some firms market product while sourcing from other licensed manufacturers.

Common industry structure for nortriptyline products

• Multiple ANDA products exist for nortriptyline tablets, usually across several strengths.
• Generic competition changes “supplier” relevance by strength and labeler; buyers often track the labeler and manufacturing site per NDC rather than the brand alone.

What companies supply generic nortriptyline that competes with Pamelor?

Direct answer: Generic nortriptyline supply comes from multiple ANDA holders that are active in the US market. In practice, the competitor set is determined by the NDC-level labeler and the ANDA listing for nortriptyline HCl tablets at each strength.

How to identify the supplier set by strength

• Determine the NDCs for Pamelor (if still marketed for that strength) and for generic nortriptyline at the same strength.
• Map each NDC to:
  • Labeler/ANDA holder
  • Manufacturing site referenced in the approved labeling
  • Market presence (in-stock status and distributor availability)

Where does the active ingredient nortriptyline come from (API suppliers)?

Direct answer: API sourcing is typically handled through qualified API suppliers that produce nortriptyline HCl to cGMP specifications. The identity of API suppliers usually is not fully disclosed publicly unless tied to DMF references, labeler disclosures, or procurement records.

How buyers identify nortriptyline API supplier networks

• DMF linkage: ANDAs and drug product applications may reference DMFs; procurement teams often use DMF and manufacturing authorization databases to identify named API manufacturers.
• Quality agreements: API suppliers are commonly selected through vendor qualification and ongoing CoA/COC workflows.

What dosage form strengths of Pamelor affect supplier availability?

Direct answer: Supplier availability is strength-specific because ANDA manufacturing lines are approved per strength and dosage form. If Pamelor is marketed only for certain presentations, that constrains who can supply equivalently.

Strength-by-strength supply risk

• Fixed strengths can face tighter supply if:
  • a manufacturing line is temporarily shut
  • a specific ANDA strength has fewer active suppliers
  • quality investigations or stability issues impact batch release

How does Pamelor supply compare with generic nortriptyline supply?

Direct answer: Brand supply is usually less diversified than generic supply because generics can be manufactured by multiple ANDA holders and sites. For nortriptyline, generic supply tends to be more resilient in most markets because many ANDA products can substitute by strength and dosing equivalence.

Buyer-facing differences

• Brand-only sourcing: reduces flexibility for procurement and tendering.
• Generic substitution: expands sourcing options, often reducing lead times.

What FDA status details determine whether a supplier can ship Pamelor?

Direct answer: Eligibility to ship finished product depends on FDA-approved labeling, manufacturing site status, and compliance history tied to the approved application for the marketed NDC.

Orange Book and listing mechanics

• Pamelor’s active ingredient is nortriptyline HCl.
• The FDA’s Orange Book lists approved products by active ingredient and includes:
  • application type
  • patent and exclusivity data (where applicable)
  • exclusivity windows that affect launch timing for competing generics

Which Pamelor generic equivalents are typically considered substitutable?

Direct answer: Substitution is usually based on:

• active ingredient: nortriptyline HCl
• dosage form: oral tablet (or the marketed form for the specific brand/strength)
• strength: matching mg per unit

Substitution constraints

• If Pamelor is only marketed for specific strengths, only those strengths have direct substitution parity from the consumer perspective.
• Bioequivalence standards apply for generics but do not guarantee identical excipient profiles.

What supply chain risks affect nortriptyline products (and by extension Pamelor)?

Direct answer: Risk drivers for nortriptyline supply typically follow generic manufacturing realities:

• limited manufacturing line capacity at certain sites for small-molecule solids
• inspection outcomes impacting batch release
• API availability if a narrow set of API producers dominates

High-impact events to monitor

• FDA enforcement actions impacting manufacturing sites
• quality recalls or distribution holds for specific NDCs
• stability or compression/coating defects for solid oral dosage forms

Key supplier sourcing workflow for procurement teams

1. Start with NDCs for the exact Pamelor presentation needed.
2. Pull the FDA-labeled manufacturer (finished dosage) from the approved labeling for that NDC.
3. Build a shortlist of generic nortriptyline NDCs that match active ingredient and strength.
4. For each shortlisted generic NDC, capture:
   • ANDA labeler/sponsor
   • manufacturing site(s)
   • market availability and lead times
5. Create a dual-sourcing plan by requiring at least two qualified manufacturers per strength, not just two labelers.

Key Takeaways

• “Pamelor suppliers” are determined at the NDC level by the FDA-labeled finished-dosage manufacturer and, for generic equivalents, by the ANDA sponsor and approved manufacturing sites.
• For nortriptyline, generic supply is usually more diversified than brand supply, making substitution supply planning practical.
• Strength-specific and site-specific manufacturing approvals drive real-world sourcing, not just the brand name.

FAQs

1. What NDCs correspond to Pamelor nortriptyline for sourcing?
2. Which generic nortriptyline ANDA sponsors are active for the same strength as Pamelor?
3. How do I identify the FDA manufacturing site for a specific nortriptyline NDC?
4. Do DMFs reveal nortriptyline HCl API manufacturers for generic products?
5. What factors most often cause nortriptyline tablet shortages at the distributor level?

References

1. U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. FDA.
2. FDA Labeling (package insert) for Pamelor (nortriptyline hydrochloride). U.S. Food and Drug Administration.