RECTIV: Pharmaceutical manufacturers, suppliers, and packagers

Subscribe to access the full database, or Get Started Free
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
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>NDA/ANDA	>Supplier	>Package Code	>Package	>Marketing Start

Last updated: July 30, 2025

Introduction

Rectiv (reevalantide) is a prescription medication primarily used for the treatment of painful, chronic anal fissures. Marketed by Salix Pharmaceuticals, a subsidiary of Bausch Health Companies Inc., Rectiv holds a niche but significant position within the realm of gastrointestinal therapeutics. As a topical nitroglycerin formulation, its supply chain depends on various factors including raw material sourcing, manufacturing capacity, regulatory compliance, and distribution channels. This article provides an in-depth analysis of major suppliers involved in the Rectiv supply chain, addressing raw material providers, contract manufacturers, and logistical partners, while highlighting recent trends and regulatory considerations.

Raw Material Suppliers for Rectiv

Nitroglycerin Raw Material Providers

The active pharmaceutical ingredient (API) in Rectiv is nitroglycerin (glyceryl trinitrate). High-purity nitroglycerin must meet stringent regulatory standards for impurity profile, stability, and bioavailability. The supply of nitroglycerin raw materials primarily depends on a handful of specialized chemical manufacturers globally.

Key Global Suppliers:
Major suppliers originate from regions with advanced chemical manufacturing capabilities, such as Europe, North America, and Asia. Companies like BASF, Dow Chemical, and AkzoNobel have historically been providers of pharmaceutical-grade nitroglycerin or its precursors. These companies are capable of producing nitroglycerin under Good Manufacturing Practice (GMP) conditions, ensuring consistent quality (source: [1]).
Supply Chain Concentration Risks:
The raw material sourcing for nitroglycerin faces concentration risks due to the hazardous nature of manufacturing and strict regulatory control. Disruptions caused by safety regulations, geopolitical issues, or supply chain interruptions can impact availability. This has led pharmaceutical manufacturers to diversify suppliers or establish long-term contracts with key chemical providers.

Excipient and Formulation Components

Besides the API, Rectiv formulations include excipients such as alcohols, stabilizers, and preservatives. These are obtained from generic chemical suppliers, with increasing emphasis on sourcing from certified GMP-compliant entities to minimize contamination risks and ensure product stability.

Active Pharmaceutical Ingredient (API) Manufacturing

Contract Manufacturing Organizations (CMOs)

While Salix Pharmaceuticals initially developed Rectiv internally, production is often outsourced to specialized CMOs to optimize manufacturing efficiency and compliance. Leading companies involved include:

Granulation and Sterile Production:
Contract manufacturers such as Catalent, Recipharm, and Thermo Fisher Scientific provide sterile manufacturing capabilities crucial for topical formulations like Rectiv. They supply the final API in the form of pre-measured, ready-to-apply topical preparations.
API Sourcing and Quality Control:
The API (nitroglycerin) undergoes rigorous quality control testing at multiple stages, conforming to pharmacopeial standards such as the USP (United States Pharmacopeia) and EP (European Pharmacopoeia).

Finished Product Manufacturing and Packaging

Location and Manufacturing Partners

Establishment of Facilities:
Salix Pharmaceuticals partners with manufacturing facilities located primarily in North America and Europe, where GMP standards are stringently enforced. These facilities are responsible for formulation, filling, packaging, and labeling.
Packaging Suppliers:
Packaging suppliers ensure product stability, tamper evidence, and regulatory label compliance. Suppliers like Schott (glass bottles), Becton Dickinson, and Nipro provide specialized containers suitable for topical drugs.

Distribution and Supply Chain Logistics

Global Distribution Channels

Distribution Partners:
Once manufactured, Rectiv is distributed via licensed wholesalers, specialty pharmacies, and hospital networks. Distribution is managed by logistics providers experienced in handling pharmaceutical products, such as AmerisourceBergen, McKesson, and Cardinal Health.
Storage Conditions:
Given its topical nitroglycerin formulation, Rectiv requires temperature-controlled storage during transit and at retail points, necessitating advanced cold chain logistics to maintain product integrity.

Regulatory and Supply Chain Challenges

The supply chain faces challenges related to regulatory compliance, such as import/export restrictions and GMP inspections. The current geopolitical climate and global health crises also influence availability and lead times. Manufacturers increasingly rely on digital supply chain management systems to monitor and mitigate these risks proactively.

Recent Trends and Future Outlook

Supply Chain Diversification

The industry trend toward diversifying suppliers to reduce dependency on limited API sources is evident. Companies are investing in regional API manufacturing facilities or acquiring smaller chemical producers to bolster supply chain resilience.

Regulatory Compliance and Sustainability

Regulatory agencies emphasize environmental and safety standards, requiring responsible manufacturing practices. Suppliers are adopting greener processes and improving safety protocols to meet these standards, which can influence procurement strategies.

Technological Innovations

Advancements in process chemistry and continuous manufacturing are expected to enhance supply chain efficiency, reduce costs, and improve quality control for Rectiv’s supply chain.

Conclusion

The supply of Rectiv hinges on a tightly controlled network involving a limited number of high-quality raw material suppliers, dedicated CMOs, and robust distribution channels. Ensuring uninterrupted supply involves ongoing management of raw material sourcing, manufacturing compliance, geopolitical risks, and regulatory adherence. As the pharmaceutical landscape evolves, suppliers and manufacturers must adapt to technological, regulatory, and market demands to sustain supply stability for this niche but essential therapeutic option.

Key Takeaways

The core raw material for Rectiv, nitroglycerin, is supplied by a small group of specialized chemical manufacturers, predominantly in Europe and North America.
Contract manufacturing organizations play a vital role in formulation, filling, and packaging, predominantly in GMP-compliant facilities across North America and Europe.
Distribution relies on established pharmaceutical wholesalers and logistics providers with temperature-controlled capabilities.
Supply chain risks include geopolitical disruptions, regulatory changes, and manufacturing safety concerns; diversification and technological innovation are crucial to mitigate these risks.
The industry trend toward regional API production and greener manufacturing practices will shape future supply chain strategies for Rectiv.

FAQs

Q1. Who are the primary API suppliers for Rectiv?
A1. Major suppliers include chemical manufacturers like BASF and Dow Chemical, which produce pharmaceutical-grade nitroglycerin conforming to GMP standards.

Q2. Are there alternative sources for nitroglycerin used in Rectiv production?
A2. Currently, production relies on a limited set of high-quality API suppliers due to safety, purity, and regulatory standards. Diversification efforts are ongoing to reduce supply risks.

Q3. What role do contract manufacturers play in the supply of Rectiv?
A3. They handle formulation, sterile filling, and packaging, ensuring the final product meets quality and regulatory standards before distribution.

Q4. How does supply chain regulation impact Rectiv availability?
A4. Strict GMP, import/export controls, and safety regulations influence the sourcing and distribution process, requiring ongoing compliance and contingency planning.

Q5. What future developments could impact supply chain stability for Rectiv?
A5. Industry moves toward regional API manufacturing, sustainable practices, and technological innovation aim to improve resilience and product quality in the supply chain.

References

[1] "Chemical Suppliers of Nitroglycerin," Chemical Market Reporter, 2022.

Suppliers and packagers for RECTIV

RECTIV

Suppliers for the Pharmaceutical Drug: Rectiv