Suppliers and packagers for RECTIV

RECTIV

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	RECTIV	nitroglycerin	OINTMENT;INTRA-ANAL	021359	NDA	Allergan, Inc.	58914-301-80	1 TUBE in 1 CARTON (58914-301-80) / 30 g in 1 TUBE	2011-06-21

Suppliers and packagers for RECTIV

Last updated: May 29, 2026

Rectiv (nitroglycerin topical) suppliers and key manufacturing sources: Who makes it and what feeds the supply chain?

Rectiv is a nitroglycerin rectal ointment (active ingredient: nitroglycerin) used for chronic anal fissure. The actionable “supplier” view for Rectiv is the contract manufacturing and packaging footprint plus upstream chemical and nitroglycerin specialty supply, with the practical import that Rectiv’s market availability is highly sensitive to site-level regulatory and production continuity at the finished-dose manufacturer and its packaging/labeling operations.

Who supplies Rectiv (nitroglycerin rectal ointment) to the U.S. market?

Rectiv’s U.S. commercial supply is tied to the labeled product’s manufacturers listed on FDA product labeling (including company addresses tied to finished dose, packaging, or distribution). The product’s regulatory dossier supply chain typically includes:

• Finished-dose manufacturing site(s) producing nitroglycerin ointment base and filling into tubes
• Packaging and labeling site(s) responsible for tube filling completion, cartons, and labeling
• Distribution entity tied to NDC distribution responsibilities

Which company manufactures Rectiv rectal ointment and where are the production sites?

Rectiv’s label and FDA registration records determine the finished-dose “manufacturing” and “packaging” responsibilities. In practice, the supplier map usually breaks into:

• Drug substance supply: nitroglycerin sourced from specialized chemical manufacturers and refined to the grade required for pharmaceutical topical use
• Drug product manufacturing: ointment compounding, extrusion or tube filling, in-process controls, and aseptic handling is not the core driver here (it is semi-solid compounding, not sterile processing)
• Primary packaging: collapsible tubes and compatible internal coatings/liners
• Secondary packaging: cartons, leaflets, and tamper-evident systems

What are the upstream chemical suppliers for nitroglycerin used in Rectiv?

Nitroglycerin is a specialized energetics-adjacent chemical used across multiple pharmaceutical and industrial applications. Upstream suppliers are typically limited and qualified due to:

• Explosive safety controls in manufacturing
• Consistency of particle attributes and impurity profiles
• Batch release testing requirements aligned with pharmaceutical specifications
• Ability to supply regulated manufacturing documentation (CoA, traceability, change control)

In a pharma supply-chain review, the “supplier” risk is not generic chemical procurement. It is the availability of pharmaceutical-grade nitroglycerin that can pass product-specific impurity and stability requirements for semi-solid formulations.

How does the sourcing of nitroglycerin affect Rectiv supply continuity?

Nitroglycerin supply continuity is driven by:

• Specialty chemical site outages or regulatory findings affecting energetics-style manufacturing lines
• Seasonal or logistics constraints tied to hazardous materials transport
• Lot-to-lot impurity shifts that can require formulation releaning or expanded testing windows for drug product release

For topical rectal ointments, shelf-life and stability specs constrain rework and substitution. If a drug substance lot does not match impurity criteria, drug product manufacturing can stall even when ointment base manufacturing capacity exists.

What contract manufacturing and packaging suppliers typically handle Rectiv?

Rectiv’s supply chain commonly includes contract manufacturing organizations (CMOs) that support:

• Ointment base compounding and homogenization
• Tube filling and sealing
• Labeling and carton packing
• Serialization and line clearance operations (if applicable in the labeling configuration)

The “who supplies” question for litigation or procurement diligence is usually answered by:

• FDA facility listings tied to drug product manufacturing and packaging responsibilities
• Labeling “Manufactured for” or “Distributed by” statements and associated addresses
• NDA or ANDA reference to the site(s) in manufacturing and control sections

What FDA and Orange Book listings show about Rectiv’s manufacturing suppliers?

Rectiv is an NDA-listed drug with a defined regulatory listing. For a supplier screen, the key information is:

• NDA holder and listed manufacturer/packager information on FDA-labeling and drug listing records
• Orange Book patent listings do not directly identify CMOs, but they show the NDA and the brand holder that controls supply-chain authorization for change notifications

Which generic or alternative nitroglycerin rectal products compete with Rectiv, and how does that change supplier leverage?

Supplier leverage rises when there is:

• Limited number of qualified nitroglycerin API sources for the pharma-grade grade
• A small number of qualified finished-dose manufacturing sites for semi-solid nitroglycerin tube products
• Switching risk for CMOs due to specialized handling constraints

A competitive landscape shift (generic entry by ANDA) can also change bargaining power for drug product CMO capacity, but only after ANDA manufacturing sites are validated and approved for commercial release.

What are the key procurement risk points in Rectiv sourcing (API, CMO, packaging)?

Procurement diligence for Rectiv typically focuses on three failure points:

1. API availability: nitroglycerin pharmaceutical-grade lot supply and impurities
2. Drug product manufacturing: ointment compounding line downtime and batch release testing capacity
3. Packaging: tube supply, closures, and labeling materials lead times

For hazardous-material APIs, lead times and transport constraints can dominate procurement schedules even when CMO capacity is available.

What supplier due diligence documents are most relevant for Rectiv procurement?

A procurement and regulatory-compliance review typically uses:

• Vendor qualification dossiers for nitroglycerin and packaging components
• GMP certificates for relevant manufacturing and packaging sites
• Change control records showing tolerance for impurity shifts and formulation parameters
• Batch manufacturing records excerpt approvals and CoA formats aligned to the drug substance specification
• Validation reports supporting aseptic controls (if any) and semi-solid mixing controls

Rectiv supplier map for business planning: how to structure a sourcing strategy

A practical supply strategy for Rectiv treats “suppliers” as a tiered dependency graph:

• Tier 0: brand/NDA holder control of labeling, supply allocation, and manufacturing change authorization
• Tier 1: finished-dose manufacturing and packaging sites producing the tube product
• Tier 2: nitroglycerin API suppliers and any API re-packaging or intermediate refining steps
• Tier 3: packaging component suppliers (tubes, liners, closures), labeling materials, and serialization systems

The key operational question is not just “who sells Rectiv,” but “which sites can maintain GMP release without extended hold times and without formulation re-verification.”

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Key Takeaways

• Rectiv’s supply is constrained by specialized nitroglycerin API sourcing plus limited qualified finished-dose and packaging sites for semi-solid rectal ointment in tubes.
• “Supplier” diligence for business use should map tiered dependencies: NDA holder, finished-dose manufacturer/packager, nitroglycerin API suppliers, and tube/labeling component suppliers.
• Primary risk points are API lot acceptance (impurity profile) and drug product release timelines at the finished-dose sites.

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FAQs

What is the active ingredient in Rectiv that drives supplier qualification?

Nitroglycerin.

Do Rectiv suppliers include both drug substance and drug product manufacturers?

Yes. Business-facing supplier maps usually split nitroglycerin API suppliers (drug substance) from finished-dose and packaging sites (drug product).

What breaks Rectiv supply most often: API shortages or packaging constraints?

For nitroglycerin topical products, API lot availability and acceptance plus hazardous-material logistics are typically the first constraint; packaging component lead times can also be limiting.

How can a procurement team validate Rectiv supply chain quality?

Use GMP site qualification, batch release CoA traceability, and change-control records for nitroglycerin API lots and finished-dose manufacturing/packaging runs.

Do Orange Book patents identify Rectiv’s manufacturing suppliers?

Orange Book listings identify the NDA and associated IP, not the day-to-day CMO/packaging suppliers directly; supplier identification is done via FDA facility/labeling records tied to the NDA product.

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References

1. FDA. Drugs@FDA: Rectiv (nitroglycerin) product information and labeling records.
2. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations.
3. FDA. NDC Directory and Drug Facility Registration (GMP establishment context).