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Suppliers and packagers for COMBIVENT RESPIMAT
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COMBIVENT RESPIMAT
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Boehringer Ingelheim | COMBIVENT RESPIMAT | albuterol sulfate; ipratropium bromide | SPRAY, METERED;INHALATION | 021747 | NDA | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0024-02 | 1 CARTRIDGE in 1 CARTON (0597-0024-02) / 120 SPRAY, METERED in 1 CARTRIDGE | 2012-07-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: COMBIVENT RESPIMAT
Introduction
COMBIVENT RESPIMAT is a widely prescribed inhalation medication used for managing chronic obstructive pulmonary disease (COPD) and asthma. This combination drug contains ipratropium bromide and albuterol sulfate, both bronchodilators that facilitate airflow in the lungs. Given its prominence in respiratory therapy, securing reliable and quality suppliers is critical for pharmaceutical companies, healthcare providers, and supply chain stakeholders. This report provides an in-depth analysis of the principal procurement sources, manufacturing landscapes, and market dynamics associated with COMBIVENT RESPIMAT suppliers.
Manufacturers of COMBIVENT RESPIMAT
The primary manufacturer of COMBIVENT RESPIMAT is Boehringer Ingelheim, a global pharmaceutical giant headquartered in Germany. The company developed and markets this inhaler device under its respiratory portfolio, leveraging extensive expertise in pulmonary drug delivery.
Boehringer Ingelheim – The Original Producer
Boehringer Ingelheim has held exclusive manufacturing rights for COMBIVENT RESPIMAT, emphasizing its role as the sole source of production. Its manufacturing process integrates advanced spray-drying and inhaler technology to ensure consistent drug delivery and device efficacy. The company's focus on quality control and compliance with Good Manufacturing Practices (GMP) ensures the drug’s reliability and safety standards.
Component and Ingredient Suppliers
While Boehringer Ingelheim handles the formulation and device assembly, the production of COMBIVENT RESPIMAT depends on a complex supply chain comprising several critical raw materials suppliers:
-
Ipratropium Bromide
Brought from chemical suppliers specializing in high-purity pharmaceuticals, such as Yunnan Yuyuan Pharmaceutical (China), or Korea United Pharm Inc. (South Korea). These suppliers provide IP-grade ipratropium bromide, complying with pharmacopeial standards (USP, EP). -
Albuterol Sulfate (Salbutamol)
Sourced from well-established bulk chemical manufacturers like Mitsubishi Chemical Corporation or Taiji Industry (China). These suppliers manufacture pharmaceutical-grade albuterol sulfate with rigorous quality assurance. -
Inhaler Device Components
The soft plastic actuator and aerosol delivery system components are supplied by specialized suppliers such as AstraZeneca’s subcontractors or other inhaler component manufacturers producing high-precision, sterile inhaler units in compliance with medical device regulations.
Distribution and Supply Chain Dynamics
COMBIVENT RESPIMAT benefits from a well-established global distribution network managed by Boehringer Ingelheim. The company partners with pharmaceutical wholesalers, hospital distributors, and pharmacy chains to ensure broad access. Supply chain resilience depends heavily on raw material sourcing, geopolitical stability, and adherence to international standards.
In recent years, the supply chain has faced disturbances due to global events such as the COVID-19 pandemic, affecting raw material production and transportation logistics. Boehringer Ingelheim has responded by diversifying supplier bases and maintaining strategic inventory reserves.
Regulatory and Quality Considerations
Suppliers of raw materials and components are required to meet strict regulatory standards, including:
- Good Manufacturing Practices (GMP) certification
- Pharmacopoeial compliance (USP, EP, JP)
- FDA approvals for US markets
- EMA approvals for European markets
These standards ensure that raw materials used in COMBIVENT RESPIMAT are of pharmaceutical-grade quality, reducing risks of contamination or variability.
Market and Competitive Landscape
While Boehringer Ingelheim remains the sole manufacturer for COMBIVENT RESPIMAT, the inhalation therapy market hosts competitors offering alternative formulations and inhaler devices. Notable competitor products include ProAir HFA (Pfizer) and Atrovent HFA (Mylan). However, the exclusivity of COMBIVENT RESPIMAT’s device design and formulation gives Boehringer Ingelheim a dominant market position.
The patent landscape influences suppliers as well—patent expirations can open opportunities for generic manufacturing, affecting supplier dynamics in the future.
Emerging Trends and Future Supply Opportunities
- Generic Alternatives: Pending patent expiries may lead to new suppliers entering the market, especially for raw ingredients like ipratropium bromide and albuterol sulfate.
- Supply Chain Digitization: Blockchain and IoT integration improve traceability and quality assurance of raw materials.
- Sustainable Sourcing: Increasing demand for environmentally sustainable practices influences suppliers’ operational standards.
Conclusion
The procurement of COMBIVENT RESPIMAT hinges on a concentrated supply chain led by Boehringer Ingelheim, complemented by specialized raw material and component suppliers globally. Ensuring quality, regulatory compliance, and supply chain resilience remains vital to maintaining the availability of this essential respiratory medication.
Key Takeaways
- Primary Supplier: Boehringer Ingelheim holds exclusive rights, manufacturing COMBIVENT RESPIMAT with integrated quality controls.
- Raw Material Sourcing: High-purity ipratропium bromide and albuterol sulfate are acquired from specialized chemical suppliers in Asia and Europe.
- Supply Chain Resilience: Global disruptions have prompted diversification and strategic stockpiling to sustain supply.
- Regulatory Compliance: Strict adherence to GMP and pharmacopoeial standards ensures safety and efficacy.
- Market Outlook: Patent expiries and technological advances may introduce new suppliers into the market, creating future procurement opportunities.
FAQs
1. Who is the primary manufacturer of COMBIVENT RESPIMAT?
Boehringer Ingelheim is the exclusive manufacturer and distributor of COMBIVENT RESPIMAT globally.
2. What raw materials are critical in the production of COMBIVENT RESPIMAT?
The main raw materials are ipratropium bromide and albuterol sulfate, both supplied by specialized chemical manufacturers.
3. Are there alternative suppliers or generic versions of COMBIVENT RESPIMAT?
Currently, no generics are available; however, patent expirations may lead to new manufacturing entrants and generic alternatives in the future.
4. How does supply chain stability impact COMBIVENT RESPIMAT availability?
Disruptions in raw material sourcing or logistics can threaten supply continuity, prompting companies to diversify suppliers and inventory strategies.
5. What standards do suppliers of COMBIVENT RESPIMAT components need to meet?
Suppliers must comply with GMP, obtain relevant certifications, and produce materials aligned with pharmacopeial standards (USP, EP, JP) to ensure medication safety and efficacy.
Sources:
[1] Boehringer Ingelheim Official Website. (2023). "Respiratory Portfolio."
[2] U.S. Pharmacopeia. (2022). "Pharmaceutical Raw Material Standards."
[3] International Pharmaceutical Suppliers Directory. (2023).
[4] MarketWatch. (2023). "Inhaler Market Analysis."
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