Bulk Pharmaceutical API Sources for PHRENILIN WITH CAFFEINE AND CODEINE

Bulk Pharmaceutical API Sources for PHRENILIN WITH CAFFEINE AND CODEINE

Vendor	Vendor Homepage	Vendor Sku	API Url
Starshine Chemical		2023-05-7C03996
RR Scientific		R6470907

Bulk Active Pharmaceutical Ingredient (API) Sources for PHRENILIN WITH CAFFEINE AND CODEINE

Last updated: November 21, 2025

Introduction

Phrenilin with Caffeine and Codeine is a combination pharmaceutical product primarily used to alleviate moderate to severe pain. Its formulation typically includes acetaminophen (paracetamol), caffeine, and codeine phosphate, a controlled opioid. The API sourcing for this medication involves procurement of each component from reputable bulk suppliers that meet strict quality standards. Ensuring pharmaceutical-grade APIs are sourced from trusted manufacturers is critical to compliance with regulatory standards, safety, and efficacy.

API Components and Their Global Suppliers

The manufacturing and procurement of each API constituent are highly specialized processes. The sources for these components are often multinational pharmaceutical ingredient suppliers with rigorous quality controls, validation processes, and compliance with good manufacturing practices (GMP).

1. Paracetamol (Acetaminophen)

As the primary analgesic component, paracetamol's API is widely produced across multiple regions, with leading suppliers ensuring high purity standards.

• Major Suppliers:

  • Cambridge Major Laboratories (U.S.) — known for high-quality API manufacturing, including paracetamol.
  • Hubei Xinowanyao Chemical Industry Co., Ltd. (China) — a significant producer offering APIs compliant with international standards.
  • Granules India (India) — a reputable supplier with a broad API portfolio, including paracetamol.
  • Zhejiang Kangle Pharmaceutical Co., Ltd. (China) — certified for manufacturing high-purity APIs.

• Quality Standards: GMP-certified, EUGMP, or FDA-approved manufacturing facilities ensure API purity (>99%), consistent batch-to-batch quality, and compliance with pharmacopeia specifications (USP, EP, or JP standards).

2. Caffeine

Caffeine, used as an adjuvant to enhance pain relief, is synthesized globally with high-volume production in China, India, and Europe.

• Major Suppliers:

  • Mitsubishi Chemical (Japan) — products meet stringent ISO and GMP standards.
  • Swinburne Chemicals (India) — offering certified caffeine APIs suitable for pharmaceutical formulations.
  • BASF (Germany) — a leading chemical supplier offering high-quality APIs including caffeine.

• Considerations: Since caffeine's synthetic process involves complex chemical synthesis, sourcing from well-established suppliers with documented quality control measures is essential.

3. Codeine Phosphate

Codeine phosphate, a Schedule II controlled substance in many countries, requires strict regulatory compliance in sourcing. It is typically produced from morphine derived from opium poppy extracts.

• Major Suppliers:

  • Halliburton (India) — a significant producer of pharmaceutical opioids, including codeine phosphate, with IRC and GMP certification.
  • Ben Venue Laboratories (U.S.) — maintains high standards for opioid APIs.
  • Sun Pharmaceutical Industries Ltd. (India) — has marketed and supplied licensed APIs, including codeine.

• Regulatory Implications: Due to strict control, sourcing codeine APIs necessitates proper licensing, import/export authorizations, and compliance with local and international regulations, such as those outlined by the DEA or EMA.

Regulatory and Quality Assurance Considerations

The procurement of APIs for products like Phrenilin with Caffeine and Codeine must adhere to stringent regulatory requirements. Suppliers should produce APIs compliant with:

• GMP standards: Ensuring consistent quality and purity.
• Pharmacopoeial specifications: USP, EP, or JP standards.
• Regulatory approvals: FDA, EMA, or other national authorities.

Audits, certificates of analysis (CoA), and quality certificates are mandatory for verifying batch quality and regulatory compliance.

Supply Chain Challenges and Strategies

• Regulatory Complexity: Codeine's scheduling status complicates procurement, especially across borders. Consider engaging with suppliers who have established regulatory pathways.
• Quality Assurance: Choose suppliers with robust QC and QA processes, including batch testing, stability testing, and adherence to international standards.
• Supply Reliability: Diversify suppliers to mitigate risks such as geopolitical issues, factory shutdowns, or regulatory hurdles.
• Cost Considerations: Balance between cost and quality; cheaper APIs may not meet strict regulatory standards, risking product rejection or recalls.

Emerging Trends and Future Outlook

• Shift towards regional manufacturing: To reduce costs and streamline supply chains, companies are increasingly sourcing APIs from regional manufacturers compliant with GMP.
• Innovation in API synthesis: The development of more sustainable, cost-effective synthetic pathways may influence future API sourcing options.
• Regulatory harmonization: Ongoing global efforts aim to standardize API quality requirements, easing cross-border procurement.

Conclusion

Sourcing high-quality APIs for Phrenilin with Caffeine and Codeine necessitates careful supplier selection aligned with regulatory frameworks, quality standards, and supply chain resilience. The prominent global suppliers, mainly based in India, China, Europe, and the U.S., continue to be vital to the manufacturing of this medication. Strategic sourcing, coupled with rigorous quality assurance, remains essential to ensuring the safety, efficacy, and regulatory compliance of finished pharmaceutical products.

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Key Takeaways

• Pharmacopoeia-compliant, GMP-certified API suppliers dominate the global supply chain for Phrenilin components.
• Major APIs—paracetamol, caffeine, and codeine phosphate—are sourced from regions with established manufacturing protocols, including India, China, and Europe.
• Due to regulatory controls, especially over codeine, licensing and compliance are critical in procurement.
• Diversification of suppliers reduces risks associated with geopolitics and supply disruptions.
• Adherence to international standards ensures product safety, reduces regulatory hurdles, and supports market expansion.

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FAQs

1. How do I verify the quality of APIs for Phrenilin with Caffeine and Codeine?
Verification involves reviewing certificates of analysis (CoA), ensuring GMP compliance, and sourcing from suppliers accredited by recognized regulatory agencies such as the FDA or EMA.

2. Are there regional restrictions on sourcing codeine APIs?
Yes, due to its controlled status, sourcing codeine requires appropriate licensing, documentation, and compliance with local and international drug control regulations.

3. What are the most reliable regions for sourcing paracetamol APIs?
India, China, and Europe are leading regions, with India and China providing cost-effective yet high-quality APIs approved by international standards.

4. How does API quality impact the finished pharmaceutical product?
API quality affects drug efficacy, safety, shelf-life, and regulatory approval. Substandard APIs can lead to recalls, legal liabilities, and compromised patient safety.

5. What emerging trends influence API sourcing strategies?
Increased regional manufacturing, improved synthetic routes, and global harmonization efforts are shaping APIs' sourcing, quality assurance, and regulatory compliance.