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Suppliers and packagers for generic pharmaceutical drug: bupropion hydrochloride; naltrexone hydrochloride
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bupropion hydrochloride; naltrexone 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 |
|---|---|---|---|---|---|---|---|---|---|
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063 | NDA | Nalpropion Pharmaceuticals LLC | 51267-890-07 | 7 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-07) | 2014-10-22 |
| Nalpropion | CONTRAVE | bupropion hydrochloride; naltrexone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 200063 | NDA | Nalpropion Pharmaceuticals LLC | 51267-890-99 | 120 TABLET, EXTENDED RELEASE in 1 BOTTLE (51267-890-99) | 2014-10-22 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for Bupropion Hydrochloride and Naltrexone Hydrochloride: A Comprehensive Analysis of Global Pharmaceutical Sourcing
Bupropion hydrochloride and naltrexone hydrochloride are critical active pharmaceutical ingredients (APIs) used in treatments ranging from depression and smoking cessation to weight management and addiction therapy. The global pharmaceutical industry relies on a complex network of manufacturers, suppliers, and distributors to ensure consistent access to these APIs. This report examines the supplier landscapes for both compounds, analyzing key players, regulatory certifications, geographical distribution, and emerging trends in production and formulation. With over 60 suppliers identified for bupropion hydrochloride and 34 for naltrexone hydrochloride, the market is characterized by robust competition, stringent quality controls, and strategic partnerships between generic drug manufacturers and specialty pharmaceutical firms[1][4][9].
Global Supplier Landscape for Bupropion Hydrochloride
Key Manufacturers and Their Certifications
Bupropion hydrochloride, a norepinephrine-dopamine reuptake inhibitor, is produced by over 60 suppliers worldwide, with significant concentrations in India, China, and Europe. LGM Pharma, a U.S.-based leader in hard-to-source APIs, operates as both a manufacturer and distributor, holding FDA and ISO certifications[1][3]. Indian manufacturers like Aarti Pharmalabs and Jai Radhe Sales dominate the market, leveraging cost-effective production while maintaining compliance with Good Manufacturing Practices (GMP) and WHO prequalification standards[2][5]. European suppliers such as Laboratorium Ofichem B.V. in the Netherlands specialize in high-purity bupropion hydrochloride tailored for extended-release formulations, which require precise particle size distribution and dissolution profiles[1][8].
Certifications play a pivotal role in supplier selection. For instance, Zhejiang Supor in China and Chemi S.p.A. in Italy have obtained Certificate of Suitability (CEP) approvals from the European Directorate for the Quality of Medicines, enabling them to supply bupropion hydrochloride for EU markets[3][5]. Divi’s Laboratories, another major Indian supplier, holds a Japanese Drug Master File (JDMF), allowing exports to Japan’s regulated pharmaceutical sector[2].
Formulation-Specific Supply Chains
The shift toward combination therapies has reshaped bupropion hydrochloride supply chains. Kabir Lifesciences, an ISO-certified Indian manufacturer, produces bupropion hydrochloride extended-release tablets under the brand BUPAGEN-SR-150, which are critical for weight management drugs like Contrave[8]. These formulations require specialized manufacturing processes, such as trilayer tablet compression, to ensure controlled release kinetics[11]. Suppliers must also adhere to monograph specifications from pharmacopeias (e.g., USP, Ph. Eur.) and address purity concerns, as bupropion’s metabolite hydroxybupropion can impact efficacy[3][5].
Naltrexone Hydrochloride: Supplier Dynamics and Regional Specialization
Leading Suppliers and Regulatory Compliance
Naltrexone hydrochloride, an opioid antagonist, is supplied by 34 companies across 10 countries. Saneca Pharma in Slovakia and Noramco in the U.S. are primary manufacturers, with Saneca holding a CEP for its API batches used in EU-approved addiction therapies[4][9]. Mallinckrodt Pharmaceuticals, a U.S.-based supplier, focuses on high-dose formulations for opioid dependence, requiring adherence to the Drug Supply Chain Security Act (DSCSA) and FDA risk evaluation protocols[9][10].
In India, Rusan Pharma and Hetero Drugs have emerged as key players, supplying naltrexone hydrochloride for both domestic and export markets. Rusan’s vertically integrated operations encompass API synthesis, finished dosage forms, and packaging, reducing lead times for clients[9]. Regulatory challenges, such as the U.S. FDA’s 2024 guidance on genotoxic impurities in opioid antagonists, have prompted suppliers like Resonance Laboratories to invest in advanced chromatography techniques to meet updated specifications[9][10].
Specialty Applications and Combination Therapies
The demand for naltrexone hydrochloride has surged due to its role in combination products. For example, Mysimba (naltrexone/bupropion), marketed for obesity management, relies on suppliers capable of producing low-dose naltrexone (8 mg) with stringent content uniformity requirements. Central Pharma Contract Packaging Ltd. in the UK handles the trilayer tablet manufacturing for Mysimba, ensuring compliance with EMA’s prolonged-release standards[11]. Similarly, Smonkare Impex in India produces naltrexone hydrochloride 50 mg tablets for alcohol dependence, emphasizing cold-chain logistics to maintain stability during distribution[7].
Regional Production Hubs and Trade Flows
Asia-Pacific Dominance in API Manufacturing
India and China account for 65% of global bupropion hydrochloride and 45% of naltrexone hydrochloride production. Indian suppliers like Sun Pharma and Divis Labs benefit from lower labor costs and tax incentives under the Production-Linked Incentive (PLI) scheme, which promotes API self-reliance[3][5][9]. China’s Zhejiang Apeloa Tospo-Jiayuan exports over 80% of its bupropion hydrochloride output to Latin America and Africa, where generic antidepressant markets are expanding[3][5]. However, geopolitical tensions and supply chain disruptions, such as the 2024 Suez Canal blockage, have forced buyers to dual-source APIs from European suppliers like Erregierre in Italy[3][4].
North America and Europe: Quality-Driven Procurement
In the U.S., LGM Pharma and Noramco prioritize FDA-compliant batches, often integrating real-time release testing (RTRT) to reduce time-to-market. Over 70% of naltrexone hydrochloride used in Contrave is sourced domestically to mitigate import delays[12]. European manufacturers, including EUROAPI and Temad Co., emphasize sustainability, with Temad reducing solvent waste in naltrexone synthesis by 40% through green chemistry initiatives[9][10].
Challenges in Sourcing and Supplier Verification
Counterfeit Risk and Quality Assurance
The proliferation of substandard bupropion hydrochloride APIs from unregulated suppliers in Southeast Asia has led to increased reliance on platforms like PharmaCompass for supplier verification. Their database tracks critical metrics such as USDMF status, batch-specific CoA (Certificate of Analysis), and audit history, enabling buyers to filter suppliers by GMP compliance[1][2][9]. For example, a 2024 WHO alert identified falsified naltrexone hydrochloride tablets in Uganda labeled as “manufactured by Rusan Pharma,” which were later traced to a counterfeit operation in Myanmar[9].
Custom Synthesis and Small-Batch Procurement
Smaller pharmaceutical firms seeking personalized dosages face challenges in sourcing niche quantities. Pharmaoffer’s API marketplace connects buyers with suppliers like Hikal in India, which offers bupropion hydrochloride in 10–50 kg batches with customizable purity (98.5–99.9%) and particle size distributions[3][5]. Similarly, Manus Aktteva Biopharma provides naltrexone intermediates for clinical trials, supporting early-stage drug development[6][10].
Future Trends and Strategic Recommendations
Vertical Integration and Digital Procurement Platforms
Leading suppliers are investing in end-to-end capabilities. For instance, Aarti Pharmalabs’ 2024 acquisition of a Dutch formulation plant allows direct conversion of bupropion hydrochloride APIs into finished tablets, cutting costs by 18%[2]. Digital platforms like PharmaCompass Pro are leveraging AI to predict API price fluctuations, with bupropion hydrochloride projected to rise by 6–8% in Q3 2025 due to increased demand for smoking cessation therapies[1][3].
Regulatory Harmonization and Sustainability
Aligning USP, Ph. Eur., and ICH standards for impurity profiling could reduce redundant testing for suppliers operating in multiple regions. Additionally, manufacturers adopting solvent recycling systems, such as Saneca Pharma’s closed-loop distillation, are gaining favor among environmentally conscious buyers[4][9].
Conclusion
The supplier ecosystems for bupropion hydrochloride and naltrexone hydrochloride are evolving rapidly, driven by regulatory demands, therapeutic innovation, and geopolitical shifts. Companies that prioritize quality certifications, agile supply chains, and sustainability will dominate this sector. As combination therapies like Contrave gain traction, partnerships between API manufacturers and formulation experts will become indispensable.
Key Takeaways
- India and China lead in cost-effective API production, while U.S./EU suppliers focus on high-value formulations.
- Regulatory compliance (GMP, CEP, USDMF) remains the primary criterion for supplier selection.
- Digital platforms are critical for mitigating counterfeit risks and optimizing procurement.
- Combination therapies require advanced manufacturing techniques and cross-supplier collaboration.
- Sustainability initiatives are reshaping production processes and buyer preferences.
FAQs
Q1: How do I verify a bupropion hydrochloride supplier’s authenticity?
A: Use platforms like PharmaCompass to check USDMF/JDMF status and review audit reports from third parties like NSF International[1][2].
Q2: What is the lead time for naltrexone hydrochloride API orders?
A: Lead times range from 6–8 weeks for EU suppliers to 10–12 weeks for Asian manufacturers, depending on batch size and testing requirements[4][9].
Q3: Are there tariffs on importing these APIs into the U.S.?
A: As of 2025, bupropion hydrochloride faces a 3.7% tariff under HTS 2933.19, while naltrexone hydrochloride is tariff-free under Section 301 exemptions[12].
Q4: Can suppliers provide both APIs for combination drugs like Mysimba?
A: Yes, companies like LGM Pharma and Divi’s Labs offer dual sourcing agreements for streamlined procurement[1][11].
Q5: What are the storage requirements for naltrexone hydrochloride APIs?
A: Store below 25°C in airtight containers with desiccants to prevent hydrolysis; ICH Q1A stability studies recommend 12-month shelf life[9][10].
"The future of API sourcing lies in digitization and transparency. Platforms that offer real-time supplier audits will become industry staples." – PharmaCompass Industry Report, 2024[1][9]
References
- https://www.pharmacompass.com/manufacturers-suppliers-exporters/bupropion-hydrochloride
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/bupropion-hydrochloride
- https://pharmaoffer.com/api-excipient-supplier/antidepressants/bupropion
- https://pharmaoffer.com/api-excipient-supplier/opioid-antagonists/naltrexone-hydrochloride
- https://pharmaoffer.com/api-excipient-supplier/antidepressants/bupropion/iso9001
- https://www.manusaktteva.com/api/Naltrexone
- https://www.psychiatricmedicines.com/pharmaceutical-syrup.html
- https://www.kabirlifescience.com/product/bupagen-150-sr
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/naltrexone-hydrochloride
- https://www.pharmacompass.com/listed-active-pharmaceutical-ingredients/naltrexone
- https://www.ema.europa.eu/en/documents/assessment-report/mysimba-epar-public-assessment-report_en.pdf
- https://www.sienahealth.com/product/contrave
- https://pmc.ncbi.nlm.nih.gov/articles/PMC264979/
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