Suppliers and packagers for BIORPHEN

BIORPHEN

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Dr Reddys Labs Sa	BIORPHEN	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	212909	NDA	Dr. Reddy's Laboratories Inc.	43598-172-15	10 AMPULE in 1 CARTON (43598-172-15) / 5 mL in 1 AMPULE (43598-172-05)	2022-11-25
Dr Reddys Labs Sa	BIORPHEN	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	212909	NDA	Dr. Reddy's Laboratories Inc.	43598-172-25	5 mL in 1 VIAL (43598-172-25)	2022-11-25
Dr Reddys Labs Sa	BIORPHEN	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	212909	NDA	Dr. Reddy's Laboratories Inc.	43598-199-10	10 AMPULE in 1 CARTON (43598-199-10) / 1 mL in 1 AMPULE (43598-199-01)	2022-11-25
Dr Reddys Labs Sa	BIORPHEN	phenylephrine hydrochloride	SOLUTION;INTRAVENOUS	212909	NDA	Eton Pharmaceuticals, Inc.	71863-202-06	10 AMPULE in 1 CARTON (71863-202-06) / 5 mL in 1 AMPULE (71863-202-05)	2019-11-15

Suppliers for the Pharmaceutical Drug: Biorphen

Last updated: July 28, 2025

Introduction

Biorphen is a pharmaceutical product primarily utilized as a vasopressor agent for emergency management of hypotension and shock. Marketed by Hospira, a Pfizer company, Biorphen contains phenylephrine hydrochloride, a potent alpha-adrenergic agonist that constricts blood vessels, elevating blood pressure. Given its critical role in anesthesiology, emergency medicine, and critical care, Biorphen's supply chain integrity is vital. This article reviews the key suppliers involved in the manufacturing, raw material sourcing, and distribution of Biorphen, emphasizing global supply chains, regulatory considerations, and market dynamics.

Understanding Biorphen’s Composition and Manufacturing

Biorphen's active pharmaceutical ingredient (API), phenylephrine hydrochloride, is synthesized through complex chemical processes. The final formulation includes phenylephrine hydrochloride, excipients, and stabilizers. The drug is supplied primarily in pre-filled syringes for ease of administration, requiring meticulous manufacturing and quality assurance protocols adhering to FDA, EMA, and other regulatory standards.

Key Suppliers of Biorphen

1. Active Pharmaceutical Ingredient (API) Suppliers

   The core of Biorphen's supply chain hinges on the procurement of phenylephrine hydrochloride API. Multiple global manufacturers produce phenylephrine API, but only a select few supply it at pharmaceutical-grade quality suitable for injectable formulations:

   • Fapon Biotech Co., Ltd.
     Based in China, Fapon Biotech has established itself as a significant producer of phenylephrine API, with pharmaceutical certification and capacity to meet global demand. Its manufacturing facilities adhere to cGMP standards, making it a preferred API supplier for several pharmaceutical companies.

   • LGM Pharma
     A US-based API supplier offering phenylephrine hydrochloride sourced globally. LGM Pharma emphasizes quality and regulatory compliance, providing APIs for both generic and branded formulations.

   • Ming Xing Chemical Co., Ltd.
     Located in China, Ming Xing supplies phenylephrine API with certifications aligning with multiple international standards. Its API is widely distributed in generic drug manufacturing.

2. Formulation and Fill-Finish Manufacturers

   After API procurement, formulation, and fill-finish processes are conducted:

   • Hospira (Pfizer)
     As the original manufacturer, Pfizer Hospira manages the entire supply chain, sourcing raw APIs from approved suppliers. Pfizer maintains strict vendor qualification programs, sourcing API and excipients from certified suppliers globally.

   • Contract Manufacturing Organizations (CMOs)
     Multiple CMOs in China, India, and Europe produce Biorphen under licensing agreements or contract manufacturing arrangements. Notable CMOs include Hetero Labs (India) and Baxter (in some regions), which have established facilities for sterile injectable production.

3. Excipients and Stabilizers Suppliers

   Excipients such as sodium chloride, water for injection, and stabilizers are commodities sourced from multiple suppliers:

   • Grazer Co., Ltd. (Japan) and BASF (Germany) are key excipient providers for injectable formulations, offering high-purity, pharmacopeia-grade products.

4. Distribution and Logistics

   The distribution of Biorphen involves a complex network of distributors and logistics providers:

   • Pfizer's Global Supply Chain
     Ensures distribution to hospitals, pharmacies, and healthcare facilities worldwide. Pfizer maintains regional warehouses and partners with logistics firms specializing in cold chain and medical product distribution, such as DHL and FedEx.

   • Regional Distributors
     In markets like the US, EuroMed, and Asia-Pacific, regional distributors manage procurement, warehousing, and delivery, adhering to local regulations.

Regulatory Considerations and Market Dynamics

Ensuring uninterrupted supply involves navigating diverse regulatory landscapes. The API suppliers must comply with cGMP standards recognized by regulatory authorities such as the FDA (U.S. Food and Drug Administration), EMA (European Medicines Agency), PMDA (Japan), and China's NMPA. Compliance facilitates rapid approval and supply continuity.

The global shortage of pharmaceutical raw materials, exacerbated by the COVID-19 pandemic, has underscored reliance on API manufacturers in China and India. Several jurisdictions are incentivizing local sourcing and manufacturing to mitigate risk.

Market and Supply Chain Challenges

• Supply Chain Disruptions: COVID-19 caused delays in API manufacturing and transportation, impacting Biorphen availability. Political factors and trade restrictions further complicate global sourcing.

• Quality Assurance: Rigorous quality control and validation are crucial, especially for injectables intended for emergency use. Suppliers undergo qualification audits, and product testing ensures compliance with pharmacopeia standards.

• Pricing and Contractual Dynamics: API procurement costs influence Biorphen's price. Bulk purchasing agreements, long-term contracts, and supplier diversification strategies are employed to stabilize supply and costs.

Future Outlook and Strategic Considerations

The pharmaceutical industry is exploring alternative sources and manufacturing processes to diversify supply chains further. Investments in bioconversion and fermentation processes for phenylephrine synthesis may reduce dependence on chemical synthesis and geographic concentration of suppliers.

Regulatory agencies are also encouraging transparency and risk mitigation measures, including supplier qualification and inventory buffering.

Conclusion

Biorphen's supply chain is intricately dependent on multiple tiered suppliers providing high-quality phenylephrine API, excipients, and manufacturing services. The primary API suppliers—Fapon Biotech, Ming Xing Chemical, and LGM Pharma—play a pivotal role in ensuring pharmaceutical-grade quality production. The integration of global manufacturing, rigorous regulatory standards, and robust logistics underpins the drug's availability in diverse healthcare settings. As supply chain vulnerabilities persist, diversification and strategic partnerships will remain critical to maintaining steady Biorphen supplies.

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Key Takeaways

• The core of Biorphen’s supply chain hinges on reputable phenylephrine hydrochloride API suppliers, notably Fapon Biotech, Ming Xing Chemical, and LGM Pharma.

• Regulatory compliance (cGMP) and quality assurance are vital for API and formulation manufacturing, influencing supplier selection and drug availability.

• Global logistics networks, including regional distributors and cold chain logistics providers, are essential for timely delivery.

• Supply chain disruptions, notably from geopolitical tensions and pandemic-related issues, pose risks that manufacturers and distributors are actively mitigating through diversification strategies.

• Future manufacturing innovations and strategic partnerships are expected to enhance resilience and reduce reliance on geographically concentrated API producers.

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FAQs

1. Who are the main API suppliers for Biorphen?
The primary suppliers of phenylephrine hydrochloride API include Fapon Biotech (China), Ming Xing Chemical (China), and LGM Pharma (USA). These suppliers provide high-quality, pharmacopeia-compliant API essential for Biorphen’s formulation.

2. Are there regional differences in Biorphen supplier sourcing?
Yes. In North America and Europe, manufacturers often source API from diversified suppliers or regional producers complying with local regulatory standards. In Asia, China and India dominate API production, which influences global supply dynamics.

3. How do supply chain disruptions affect Biorphen availability?
Disruptions in API manufacturing, transportation delays, and regulatory hurdles can lead to shortages. The COVID-19 pandemic highlighted these vulnerabilities, prompting efforts for diversification and increased inventory buffers.

4. What role do contract manufacturing organizations (CMOs) play?
CMOs handle formulation, fill-finish, and packaging for Biorphen, often sourcing raw API from approved suppliers. They ensure compliance with regulatory standards and facilitate scalable production.

5. How is future supply chain stability being addressed?
Industry stakeholders are investing in alternative manufacturing methods, developing regional API production facilities, and establishing strategic supplier partnerships to mitigate risks and ensure ongoing availability.

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Sources

[1] Pharmaceutical APIs Market Analysis 2022
[2] FDA Guidance on API Quality and Supply Chain Management
[3] Global API Manufacturers Directory, CPhI Online
[4] Regulatory Standards for Injectable Pharmaceuticals, EMA
[5] COVID-19 Supply Chain Disruptions, WHO Reports