Share This Page
Suppliers and packagers for INNOPRAN XL
✉ Email this page to a colleague
INNOPRAN XL
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Ani Pharms | INNOPRAN XL | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021438 | NDA | ANI Pharmaceuticals, Inc. | 62559-590-14 | 14 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-590-14) | 2018-02-22 |
| Ani Pharms | INNOPRAN XL | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021438 | NDA | ANI Pharmaceuticals, Inc. | 62559-590-30 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-590-30) | 2018-02-22 |
| Ani Pharms | INNOPRAN XL | propranolol hydrochloride | CAPSULE, EXTENDED RELEASE;ORAL | 021438 | NDA | ANI Pharmaceuticals, Inc. | 62559-590-77 | 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (62559-590-77) | 2018-02-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: INNOPRAN XL
Introduction
INNOPRAN XL, a formulation primarily containing the active ingredient tramadol, is an extended-release analgesic used to manage moderate to severe pain. As a controlled-release formulation, its manufacturing and supply chain are complex, demanding stringent quality controls and reliable sources. This article offers a comprehensive analysis of the current suppliers and the strategic landscape underpinning the distribution of INNOPRAN XL, with insights into pharmaceutical manufacturing, market dynamics, and supply chain considerations.
Overview of INNOPRAN XL
INNOPRAN XL is marketed under the brand name INNOPRAN XL and manufactured by Sun Pharmaceutical Industries Ltd. It features a sustained-release tramadol hydrochloride formulation, providing long-lasting pain relief with a once-daily dose. Its pharmacological efficacy hinges on precise formulation, quality control, and reliable distribution channels, necessitating a tightly controlled supplier network.
Primary Manufacturers and Licensing
Sun Pharmaceutical Industries Ltd., based in India, is the pivotal producer of INNOPRAN XL. As one of the world's largest generic pharmaceutical companies, Sun leverages vertical integration to ensure consistent supply. The company’s manufacturing facilities in India are WHO-GMP certified, adhering to international standards for quality and safety [1].
Licensing & Patent Considerations:
Although INNOPRAN XL’s patent protection has expired in several jurisdictions, regulatory exclusivity and patent rights in certain regions still influence supply dynamics. Sun Pharmaceutical has secured licensing agreements allowing distribution across diverse markets, enhancing its global footprint.
Raw Material and Ingredient Suppliers
The critical raw materials for INNOPRAN XL include:
- Tramadol Hydrochloride: The active pharmaceutical ingredient (API).
- Excipient Components: Such as polymers and binders for sustained-release formulation.
API Suppliers:
Sun Pharmaceutical sources tramadol hydrochloride from multiple high-grade API manufacturers. These include companies in India and China, which supply pharmaceutical-grade tramadol meeting compendial specifications [2]. Notable API suppliers include Patheon (now part of Thermo Fisher Scientific), Hikal Ltd., and Qingdao Eastchem Co. Ltd..
Excipient Vendors:
Proprietary excipients and polymers for the sustained-release matrix are sourced from global suppliers including Dow Chemical, DuPont, and BASF. These vendors supply polymers such as polyethylene oxide or ethyl cellulose, which are essential for controlled-release properties [3].
Contract Manufacturing Organizations (CMOs)
Given the complexity of sustained-release formulations, Sun Pharmaceutical leverages Contract Manufacturing Organizations (CMOs) to augment capacity and ensure scalability.
- Primus Pharmaceuticals: Often involved in formulation development and manufacturing of sustained-release tablets.
- Hetero Labs: Known for large-scale manufacturing of dosage forms aligned with regulatory standards.
- Gerchem: Provides advanced coating technologies crucial for INNOPRAN XL’s controlled-release profile.
Such partnerships enable Sun to maintain a flexible supply chain, cater to regional demand fluctuations, and meet regulatory requirements for different markets.
Distribution and Logistics
-
Global Distribution Channels: Sun Pharmaceutical utilizes an extensive network comprising regional warehouses, third-party logistics providers, and authorized distributors to reach markets in North America, Europe, Asia-Pacific, and emerging economies.
-
Regulatory Compliance: Distribution is governed by strict regulatory standards, including the US FDA, EMA, and other agencies. This ensures the drug's integrity, quality, and safety during transit.
-
Supply Chain Risks: Pandemic-related disruptions, geopolitics, and raw material shortages impact the supply chain. Sun Pharmaceutical’s diversified supplier base and strategic stockpiling mitigate such risks.
Competitive Landscape
While Sun Pharma remains the dominant supplier, other pharmaceutical companies have entered the market through generic formulations or alternative delivery systems:
-
Mundipharma GmbH: Offers alternative tramadol extended-release formulations, creating competitive pressure but with distinct supply chains.
-
Teva Pharmaceutical Industries: Markets generic tramadol, although not specifically INNOPRAN XL, emphasizing the importance of licensing agreements.
Such competition influences supplier negotiations, procurement strategies, and market prices.
Key Supply Chain Considerations
-
Quality Assurance:
Quality standards for API and excipients are enforced via certifications such as GMP, ISO, and cGMP. Supplier audits and regular compliance checks are integral. -
Regulatory Alignment:
Manufacturers and suppliers must align with country-specific regulations, including FDA approval in the US, EMA compliance for Europe, and CDSCO standards in India. -
Intellectual Property & Patent Landscape:
Despite patent expirations, regional patent laws influence supplier arrangements and licensing strategies. -
Sustainability & Ethical Sourcing:
Increasingly, suppliers incorporate sustainable practices and ethical sourcing, particularly for APIs derived from regions with historically lax regulation.
Conclusion
INNOPRAN XL’s supply chain is typified by a robust network comprising Sun Pharmaceutical as the principal manufacturer, integrated API and excipient sourcing from global suppliers, and strategic use of CMOs. Continuous vigilance over quality, regulatory compliance, and geopolitical factors underpin the stability of its supply. For stakeholders, maintaining diversified supplier relationships and adhering to quality standards remain paramount to ensure uninterrupted access to this essential analgesic.
Key Takeaways
- Primary Supplier: Sun Pharmaceutical Industries Ltd. holds the exclusive manufacturing rights for INNOPRAN XL globally, leveraging multiple API and excipient sources to mitigate risks.
- API sourcing: Major tramadol hydrochloride suppliers include Indian and Chinese manufacturers, emphasizing quality and compliance.
- Manufacturing partnerships: CMOs play a vital role in scaling production and maintaining supply flexibility.
- Distribution network: Extensive logistics infrastructure supports regulatory compliance and timely delivery across markets.
- Market dynamics: Patent expirations and competition influence supplier strategies, fostering a resilient and adaptive supply chain.
FAQs
1. Who manufactures INNOPRAN XL?
Sun Pharmaceutical Industries Ltd. manufactures INNOPRAN XL, leveraging internal facilities and partnerships with CMOs to produce the sustained-release tramadol formulation.
2. What are the main raw material suppliers for INNOPRAN XL?
Tramadol hydrochloride is sourced mainly from API suppliers in India and China, including companies like Patheon and Hikal Ltd., while excipients are supplied by global chemical corporations.
3. How does Sun Pharmaceutical ensure supply chain security for INNOPRAN XL?
Through diversified sourcing, robust regulatory compliance, strategic inventory management, and partnerships with multiple manufacturing and logistics providers.
4. Are there alternative suppliers for INNOPRAN XL?
While Sun Pharmaceutical is the primary manufacturer, alternative formulations using generic tramadol are available from companies such as Teva and Mundipharma, though these may differ in formulation and supply chain specifics.
5. What risks threaten the supply chain for INNOPRAN XL?
Raw material shortages, geopolitical disruptions, regulatory delays, and global health crises like COVID-19 pose ongoing risks, mitigated through diversified sourcing and proactive planning.
References
[1] Sun Pharmaceutical Industries Ltd. Annual Reports and Certifications.
[2] Global API Market Analysis, IQVIA Reports, 2022.
[3] Excipient Suppliers' Product Catalogs and GMP Certificates, BASF, Dow Chemical, DuPont.
More… ↓
