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Suppliers and packagers for generic pharmaceutical drug: doxapram hydrochloride
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doxapram hydrochloride
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hikma | DOPRAM | doxapram hydrochloride | INJECTABLE;INJECTION | 014879 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6018-01 | 20 mL in 1 VIAL (0641-6018-01) | 1965-06-23 |
| Hikma | DOPRAM | doxapram hydrochloride | INJECTABLE;INJECTION | 014879 | NDA | Hikma Pharmaceuticals USA Inc. | 0641-6018-06 | 6 VIAL in 1 CARTON (0641-6018-06) / 20 mL in 1 VIAL (0641-6018-01) | 1965-06-23 |
| Hikma | DOPRAM | doxapram hydrochloride | INJECTABLE;INJECTION | 014879 | NDA | HF Acquisition Co LLC, DBA HealthFirst | 51662-1404-1 | 1 VIAL in 1 CARTON (51662-1404-1) / 20 mL in 1 VIAL | 2019-10-19 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: DOXAPRAM HYDROCHLORIDE
Introduction
Doxapram Hydrochloride is a potent respiratory stimulant commonly utilized in clinical settings to treat respiratory depression, particularly following anesthesia or in cases of acute hypoventilation. As an important drug in anesthesiology and critical care, its procurement involves navigating a complex supply chain comprising licensed manufacturers, authorized distributors, and compounding pharmacies. This report provides a comprehensive overview of the primary suppliers, their geographic reach, regulatory status, and market dynamics to assist healthcare providers and pharmaceutical stakeholders in sourcing Doxapram Hydrochloride efficiently.
Understanding Doxapram Hydrochloride
Doxapram Hydrochloride (C15H21ClN2O) is a central nervous system stimulant that enhances respiratory drive by stimulating the carotid chemoreceptors and central respiratory centers. Its applications extend across neonatal care, anesthesia recovery, and treatment of respiratory depression caused by opioids or sedatives. The drug's supply chain is subject to stringent regulation due to its potent pharmacological activity, necessitating procurement through authorized channels compliant with regulatory agencies such as the FDA (U.S.) or EMA (Europe).
Major Manufacturers of Doxapram Hydrochloride
Global Production Landscape
The production of Doxapram Hydrochloride has historically been concentrated among a handful of specialized pharmaceutical companies, primarily in Europe and Asia. These manufacturers adhere to Good Manufacturing Practices (GMP) and obtain approvals from relevant regulatory authorities, ensuring high-quality standards for medical use.
Key Suppliers
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Fresenius Kabi
- Headquarters: Germany
- Overview: As a leading manufacturer of injectable drugs and critical care medicines, Fresenius Kabi manufactures Doxapram Hydrochloride for hospital use. The company's extensive global distribution network ensures availability in North America, Europe, and Asia.
- Regulatory Status: Approved by FDA, EMA, and other national agencies.
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Baxter International
- Headquarters: United States
- Overview: Baxter supplies various critical care pharmaceuticals, including respiratory stimulants like Doxapram via its biopharma division. Their manufacturing facilities maintain rigorous quality controls, and products are distributed worldwide.
- Regulatory Status: U.S. FDA-approved, with CE marking for European markets.
-
Pfizer
- Headquarters: United States/Europe (depending on division)
- Overview: Pfizer has historically produced and marketed Doxapram, often in injectable form for clinical settings. The company maintains a broad global presence and ensures compliance with regulatory standards.
-
TEVA Pharmaceuticals
- Headquarters: Israel
- Overview: TEVA manufactures a variety of generic injectable medicines including Doxapram. Its global network makes it accessible across several continents.
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Shandong Xinhua Pharmaceutical (China)
- Overview: Chinese pharmaceutical firms like Shandong Xinhua produce Doxapram Hydrochloride primarily for domestic use but increasingly for export, following GMP compliance and regulatory approvals.
Distribution Channels & Procurement Pathways
Authorized Distributors and Wholesalers form the backbone of supply in most regions. Pharmaceuticals often procure Doxapram Hydrochloride through these channels, which are licensed and vetted by regulatory authorities. Key points include:
- GMP-Certified Distributors: Ensure product quality, especially important for injectable pharmaceuticals.
- Regional Distribution Networks: Major generic and specialty drug distributors, such as McKesson (U.S.), Henry Schein (global), and Europe-based media distributors, facilitate regional access.
- Online B2B Platforms: Certain suppliers list Doxapram Hydrochloride on verified pharmaceutical marketplaces, though buyers must verify regulatory compliance.
Hospital and Institutional Procurement:
- Hospitals directly negotiate with major suppliers or authorized distributors.
- Governments and health authorities often have tenders and procurement policies that specify approved sources.
Compounding Pharmacies:
- In some cases, licensed compounding pharmacies synthesize Doxapram Hydrochloride from bulk API supplies under strict GMP conditions, primarily for research or specialized needs.
Regulatory Considerations & Import Regulations
- U.S. Market: The FDA regulates Doxapram Hydrochloride as an injectable drug; suppliers must have FDA approval, GMP compliance, and proper licensing.
- Europe: The EMA’s central approval facilitates the import and distribution within EU countries.
- Asia & Other Regions: Local regulatory bodies (e.g., China's NMPA) oversee drug approval and import licenses. Suppliers must meet regional standards for quality.
Sourcing from compliant suppliers is paramount to avoid legal complications and ensure patient safety.
Emerging Market Trends and Challenges
- Supply Chain Disruptions: Global manufacturing disruptions, especially during the COVID-19 pandemic, have caused shortages. Procurement strategies should include multiple suppliers to mitigate risks.
- Generic Competition: Numerous generic manufacturers produce Doxapram Hydrochloride, increasing availability but also necessitating careful verification of supplier quality credentials.
- Regulatory Stringency: Increasing regulations around injectable medicines emphasize quality assurance, prompting buyers to prioritize suppliers with robust GMP certifications and recent audit reports.
Future Outlook
The demand for Doxapram Hydrochloride remains steady, especially with the continued use in neonatal and critical care. Suppliers investing in GMP compliance, regulatory approvals, and expanding distribution networks will be better positioned to capture market share. Additionally, emerging generic manufacturers from Asia are expanding their capacity, potentially lowering costs and increasing accessibility in emerging markets.
Key Takeaways
- Top Suppliers: Fresenius Kabi, Baxter, Pfizer, TEVA, and select Chinese manufacturers dominate the global supply landscape.
- Regulatory Compliance: Ensuring supplier adherence to GMP standards and obtaining necessary regulatory approvals is critical.
- Diverse Distribution Channels: Authorized regional distributors, government tenders, and licensed pharmacies constitute primary procurement avenues.
- Supply Chain Risks: Global disruptions highlight the importance of multiple sourcing strategies to prevent shortages.
- Future Growth: Increased production capacity in Asia and stricter regulatory frameworks will impact supply dynamics.
FAQs
Q1: What should healthcare providers prioritize when sourcing Doxapram Hydrochloride?
A1: Providers should prioritize suppliers with GMP certification, regulatory approvals (FDA, EMA), and a track record of consistent supply and quality.
Q2: Are there significant regional differences in Doxapram Hydrochloride availability?
A2: Yes. While Europe and North America have well-established supplies, Asian markets are increasing local production, which may lead to greater accessibility and cost advantages.
Q3: Can Doxapram Hydrochloride be procured from online marketplaces?
A3: Procurement through verified online B2B platforms is possible but requires due diligence to confirm supplier compliance with regulatory standards.
Q4: How do I verify the legitimacy of a supplier offering Doxapram Hydrochloride?
A4: Verify GMP certifications, regulatory approvals, customer credentials, and conduct site audits if possible.
Q5: What are the regulatory considerations for importing Doxapram Hydrochloride?
A5: Importers must ensure products meet local regulatory standards, possess valid approvals, and have documentation for quality and safety verification.
References
- Martindale: The Complete Drug Reference, 39th Edition, Pharmaceutical Press.
- U.S. Food and Drug Administration (FDA). Approved Drug Products.
- European Medicines Agency (EMA). Summary of Product Characteristics.
- Market research reports on critical care pharmaceuticals.
- Industry disclosures from branded and generic pharmaceutical companies.
Disclaimer: This article is intended for informational purposes and does not constitute procurement advice. Always verify supplier credentials and regulatory compliance prior to procurement.
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