Suppliers and packagers for butapap

butapap

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Anda Repository	BUTAPAP	acetaminophen; butalbital	TABLET;ORAL	089987	ANDA	Endo USA	0603-2540-21	100 TABLET in 1 BOTTLE (0603-2540-21)	1999-06-03
Anda Repository	BUTAPAP	acetaminophen; butalbital	TABLET;ORAL	089987	ANDA	El Dorado Distributors LLC	11584-0030-1	100 TABLET in 1 BOTTLE, PLASTIC (11584-0030-1)	2013-10-10

Suppliers for the Pharmaceutical Drug: BUTAPAP

Last updated: August 5, 2025

Introduction
Butapap, a combination analgesic containing paracetamol (acetaminophen) and butalbital, is used primarily for the management of tension headaches and other moderate pain conditions. As a prescription medication, supply chain dynamics, manufacturing sources, and regulatory considerations significantly influence availability and distribution. This analysis explores the key suppliers, manufacturing landscape, and strategic considerations pertinent to Butapap, providing business professionals with essential insights into its global supply network.

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Overview of Butapap Composition and Market Context
Butapap combines paracetamol’s analgesic and antipyretic properties with butalbital’s sedative effects, delivering a multipronged approach for headache relief. While widely used historically, butalbital-containing formulations face regulatory scrutiny globally due to abuse potential and side effects. Consequently, many jurisdictions have restricted or banned such compounds, impacting supplier markets and supply chains.

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Global Manufacturing Landscape

1. Manufacturing Regions and Key Players
The supply of Butapap is concentrated among pharmaceutical companies operating within specific regulatory environments. Historically, sourcing has been prominent in:

• India: Known for generic drug production, India supplies both active pharmaceutical ingredients (APIs) and finished formulations. Major API manufacturers such as Sun Pharmaceutical Industries, Cadila Healthcare, and Lupin produce importing-grade paracetamol and butalbital. However, due to regulatory shifts, the manufacturing of butalbital-containing products has declined.

• China: China is a significant API supplier for paracetamol and related compounds, with companies like Zhejiang Hisun Pharmaceutical and Anhui Tiger Pharmaceutical contributing to bulk API supplies. Nonetheless, restrictions on controlled substances like butalbital limit Chinese production of combination drugs containing barbiturates.

• United States and Europe: Regulatory agencies like the FDA and EMA tightly control butalbital formulations, mostly limiting manufacturing to licensed pharmaceutical companies. Domestic producers include North American and European pharmaceutical firms that adhere strictly to Good Manufacturing Practices (GMP).

2. API Suppliers for Paracetamol
Paracetamol’s API is India, China, and to a lesser extent, European manufacturers’ core product, with supply chains highly competitive and often integrated into finished drug production.

3. Barbiturate (Butalbital) Manufacturers
Butalbital is classified as a controlled substance (Schedule III in the US), making manufacturing and distribution tightly regulated. Only a few licensed companies possess the requisite licenses to produce pharmaceutical-grade butalbital, predominantly within the US and some European countries.

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Regulatory Environment and Impact on Suppliers
The regulatory landscape significantly impacts suppliers. Many countries have imposed restrictions due to the misuse potential of barbiturates, leading to:

• Manufacturing bans or suspensions in certain jurisdictions, notably Canada and some European nations, where butalbital drugs are heavily limited or no longer approved.
• Shift in supply sources: Companies have transitioned to alternative combination therapies or formulations without butalbital, reducing overall supplier options.

4. Major Suppliers and Contract Manufacturers
Given the niche and regulatory constraints, few global firms serve as primary suppliers for Butapap:

• Chemical intermediates suppliers: Focused on api-grade paracetamol, with major companies such as Akorn, Mylan, and Zhejiang Hisun.
• Finished drug manufacturers: Licensed pharmaceutical producers within the US, such as Valeant Pharmaceuticals (now part of Bausch Health), have historically supplied butalbital formulations.

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Supply Chain Challenges and Trends

1. Supply Disruption Risks

• Regulatory crackdowns on barbiturates have led to supply shortages in some markets.
• Geopolitical factors, including trade restrictions and export controls, impact API and finished product availability.
• Quality concerns and GMP compliance influence supplier selection, given the critical need for safety and efficacy.

2. Market Trends

• The decline in demand for butalbital-based formulations due to safety concerns has decreased the number of active suppliers.
• Increased manufacturing costs, coupled with stringent regulation, have led some companies to discontinue production, consolidating supply chains.

3. Alternative Therapies

• Several markets shift toward non-barbiturate combinations or formulations, further constraining supply chain options for traditional Butapap.

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Strategic Considerations for Stakeholders

Business professionals seeking to ensure a reliable supply chain must evaluate:

• Regulatory compliance: Partner with licensed, GMP-certified manufacturers compliant with local laws.
• Supply chain transparency: Verify the origin of APIs and finished products through documentation and audits.
• Alternative sourcing: Consider suppliers outside traditional regions, such as India or China, especially for paracetamol, while acknowledging restrictions on butalbital importation.

Regulatory and Legal Risks
Given the Controlled Substances Act (CSA) regulations in the US and similar European directives, import and export controls pose notable risks. Ensuring compliance is crucial for uninterrupted supply.

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Concluding Remarks

The supply landscape for Butapap is highly specialized, constrained by regulatory controls on its key components, especially butalbital. Most available suppliers are concentrated in jurisdictions with strict licensing and GMP standards, including major pharmaceutical firms in the US, India, and Europe. Supply continuity remains challenged by regulatory shifts, necessitating proactive sourcing strategies and contingency planning.

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Key Takeaways

• The primary suppliers for paracetamol are predominantly based in India and China, with globally established manufacturing networks ensuring broad availability for raw API procurement.
• Butalbital, being a controlled substance, limits supplier options mainly to licensed manufacturers within the US and select European countries, significantly constraining global supply.
• Regulatory restrictions and safety concerns have led to a decline in production and distribution of Butapap, prompting market shifts toward alternative pain management formulations.
• Businesses should prioritize suppliers with strict GMP compliance, regulatory approval, and transparent supply chains to mitigate legal and quality risks.
• Strategic diversification, regulatory intelligence, and adherence to international drug laws are critical for maintaining a secure supply chain for Butapap.

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Frequently Asked Questions (FAQs)

1. What are the leading regions manufacturing APIs for Butapap?
India and China dominate the API market for paracetamol; however, due to regulatory constraints, production of butalbital-containing formulations is limited to licensed manufacturers primarily in the US.

2. Are there alternative suppliers for Butapap due to regulatory restrictions?
Yes, alternative formulations and non-barbiturate combinations are increasingly available, although sourcing pure Butapap remains challenging due to regulatory controls on butalbital.

3. How do legal restrictions impact global supply chains for Butapap?
Strict regulations on controlled substances such as butalbital restrict production and distribution, resulting in supply shortages and increased procurement complexity in many jurisdictions.

4. How can companies ensure the quality and compliance of their suppliers?
By engaging with GMP-certified suppliers, conducting regular audits, verifying documentation for APIs and finished products, and aligning with regulatory standards in target markets.

5. What is the future outlook for Butapap suppliers?
Market decline due to safety concerns suggests a shrinking pool of suppliers. Companies must adapt by exploring alternative therapies and ensuring regulatory compliance to sustain supply chains.

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References
[1] U.S. Food and Drug Administration (FDA). Controlled Substances Act. 2022.
[2] European Medicines Agency (EMA). Regulatory restrictions on barbiturates. 2022.
[3] Indian Drug Regulator. API manufacturing guidelines. 2022.
[4] Chinese National Medical Products Administration (NMPA). API manufacturing and registration standards. 2022.