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Suppliers and packagers for generic pharmaceutical drug: ammonium lactate
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ammonium lactate
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Padagis Israel | AMMONIUM LACTATE | ammonium lactate | CREAM;TOPICAL | 075774 | ANDA | Padagis Israel Pharmaceuticals Ltd | 45802-493-26 | 385 g in 1 BOTTLE, PUMP (45802-493-26) | 2006-08-16 |
| Padagis Israel | AMMONIUM LACTATE | ammonium lactate | CREAM;TOPICAL | 075774 | ANDA | Bryant Ranch Prepack | 63629-8608-1 | 2 TUBE in 1 CARTON (63629-8608-1) / 140 g in 1 TUBE | 2006-08-16 |
| Padagis Israel | AMMONIUM LACTATE | ammonium lactate | CREAM;TOPICAL | 075774 | ANDA | Bryant Ranch Prepack | 63629-8609-1 | 385 g in 1 BOTTLE, PUMP (63629-8609-1) | 2006-08-16 |
| Padagis Israel | AMMONIUM LACTATE | ammonium lactate | CREAM;TOPICAL | 075774 | ANDA | Bryant Ranch Prepack | 72162-1413-2 | 2 TUBE in 1 CARTON (72162-1413-2) / 140 g in 1 TUBE | 2006-08-16 |
| Sun Pharma Canada | AMMONIUM LACTATE | ammonium lactate | CREAM;TOPICAL | 075883 | ANDA | Sun Pharmaceutical Industries, Inc. | 51672-1301-0 | 385 g in 1 BOTTLE, PLASTIC (51672-1301-0) | 2003-04-10 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Ammonium Lactate
Introduction
Ammonium lactate is a widely used pharmaceutical and dermatological active ingredient, primarily formulated for moisturizing and treating dry, scaly skin conditions. Its efficacy as a humectant and keratolytic agent makes it a staple in various topical formulations. With increasing demand driven by an aging population and rising dermatological disorders, identifying reliable suppliers for ammonium lactate has become critical for pharmaceutical companies, skincare formulators, and distributors.
This article provides a comprehensive overview of the key suppliers for ammonium lactate, examining their manufacturing capabilities, geographical distribution, certifications, and market positioning. Understanding the landscape of suppliers enables stakeholders to make informed procurement decisions, ensure product quality, and maintain supply chain resilience.
Overview of Ammonium Lactate Manufacturing
Ammonium lactate is produced through chemical synthesis, involving the neutralization of lactic acid with ammonium hydroxide, followed by purification processes. The global production landscape comprises several large-scale and regional manufacturers, with North America, Europe, and Asia serving as significant hubs.
The quality and purity standards for pharmaceutical-grade ammonium lactate demand adherence to pharmacopeias such as USP (United States Pharmacopeia), EP (European Pharmacopoeia), and BP (British Pharmacopoeia), which necessitate robust manufacturing processes and quality control measures.
Major Suppliers of Ammonium Lactate
1. BASF SE (Germany)
Overview:
BASF is among the world's leading chemical producers, with a strong presence in the specialty chemicals market, including pharmaceutical excipients and active ingredients.
Capabilities:
- Manufactures high-purity ammonium lactate suitable for pharmaceutical and cosmetic applications.
- Extensive infrastructure that supports large-scale production with rigorous quality assurance protocols.
Certifications:
- ISO 9001, ISO 14001, GMP certification (Good Manufacturing Practice).
- Supplies to global pharmaceutical companies adhering to strict regulatory standards.
Market Position:
- Recognized for consistent quality and reliability, supplying to both finished pharmaceutical products and raw material vendors.
2. Lonza Group (Switzerland)
Overview:
Lonza is a global leader in custom manufacturing for pharmaceuticals, biotechnologies, and specialty chemicals.
Capabilities:
- Produces pharmaceutical-grade ammonium lactate under stringent quality standards.
- Offers contract manufacturing and custom synthesis services, including stability and formulation support.
Certifications:
- GMP-compliant manufacturing.
- ISO 9001, 14001 certifications.
Market Position:
- Trusted partner for multinational pharmaceutical firms seeking high-quality active pharmaceutical ingredients (APIs).
3. Ashland Global Holdings Inc. (USA)
Overview:
Ashland specializes in specialty ingredients for health and personal care markets.
Capabilities:
- Supplies pharmaceutical-grade ammonium lactate, primarily targeting dermatological and skincare formulations.
- R&D support for custom formulations and stability testing.
Certifications:
- GMP, ISO certifications.
Market Position:
- Strong regional presence in North America and Europe with a focus on cosmetic and personal care applications.
4. Symrise AG (Germany)
Overview:
Symrise serves the flavor, fragrance, and active ingredients segments, including pharmaceutical excipients.
Capabilities:
- Produces high-quality ammonium lactate for topical and dermatological uses.
- Emphasizes sustainable sourcing and environmentally friendly manufacturing processes.
Certifications:
- ISO 9001, 14001, GMP.
Market Position:
- Positioned as a premium supplier aligning with eco-conscious pharmaceutical and cosmetic companies.
5. Tianjin Zhongxin Pharmaceutical Group Co., Ltd. (China)
Overview:
A key regional manufacturer with growing international presence.
Capabilities:
- Provides pharmaceutical-grade ammonium lactate at competitive prices, primarily targeting Asian markets but expanding globally.
- Offers comprehensive APIs with certifications for export to regulated markets.
Certifications:
- cGMP, ISO 9001, and local Chinese certifications.
Market Position:
- Cost-effective supplier for formulators prioritizing affordability without compromising quality.
Emerging and Regional Players
Apart from the above, several regional companies serve local markets, especially in Asia and Eastern Europe, with varying certifications and quality standards. Examples include:
- Macleods Pharmaceuticals (India): Focuses on pharmaceutical excipients, including ammonium lactate, with a growing export footprint.
- Mitsubishi Chemical (Japan): Offers specialty chemicals, including formulations with ammonium lactate, emphasizing innovation and quality.
Key Considerations for Selecting Suppliers
Regulatory Compliance:
Prioritize suppliers with certifications such as GMP, ISO, and relevant pharmacopeial approvals to ensure product quality and safety.
Supply Capacity and Reliability:
Assess manufacturing capacities, lead times, and contingency plans to prevent supply disruptions.
Quality Assurance and Testing:
Ensure suppliers conduct rigorous testing for purity, stability, and contaminant levels, complying with pharmacopoeial standards.
Pricing and Flexibility:
Balance cost considerations with quality and flexibility in order quantities and customization.
Environmental and Ethical Standards:
Choose suppliers committed to sustainable practices and environmental responsibility, aligning with corporate social responsibility goals.
Market Trends & Future Outlook
The global ammonium lactate market is projected to grow steadily, driven by increased demand in dermatology, anti-aging skincare, and cosmetic formulations. The expansion of organic and natural cosmetic products elevates the importance of suppliers that adhere to sustainable manufacturing practices.
Growth in emerging markets, especially Asia-Pacific, alongside stringent regulatory frameworks in North America and Europe, will influence supplier selection criteria. Suppliers investing in R&D to improve product purity, reduce environmental impact, and develop formulations with enhanced efficacy will maintain competitive advantage.
Key Takeaways
- Leading global suppliers such as BASF, Lonza, and Ashland dominate the ammonium lactate market, providing high-quality, pharmacopeia-compliant products.
- Regional manufacturers offer competitive pricing, especially relevant for emerging markets, but must meet stringent regulatory standards to ensure product safety.
- Quality assurance, including GMP certification and rigorous testing, remains vital in supplier evaluation for pharmaceutical applications.
- Supply chain resilience depends on diversifying sources and maintaining strong relationships with multiple suppliers.
- Sustainability practices are increasingly influencing supplier selection, aligning corporate environmental commitments with procurement strategies.
FAQs
1. What are the key quality standards for ammonium lactate in pharmaceuticals?
Pharmaceutical-grade ammonium lactate must conform to standards set by pharmacopeias such as USP, EP, and BP, which specify purity levels, contaminant thresholds, and testing protocols.
2. How do I verify a supplier's regulatory compliance?
Request documentation of GMP certification, recent audit reports, and certificates of analysis (COA). Suppliers should also demonstrate compliance with region-specific regulations like FDA (US), EMA (Europe), or CFDA (China).
3. Is it possible to find suppliers offering custom formulations of ammonium lactate?
Yes, contract manufacturing organizations such as Lonza and others offer custom synthesis and formulation services to tailor ammonium lactate products for specific client requirements.
4. What are the sourcing considerations for companies targeting emerging markets?
Cost-effectiveness, regional certifications, and supply reliability are critical. Evaluate regional suppliers with proven track records and compliance with local regulations.
5. How sustainable are the manufacturing processes for ammonium lactate?
While many leading suppliers adhere to sustainability standards like ISO 14001 and environmentally conscious manufacturing practices, assessing each supplier’s environmental policies is essential for aligning procurement with corporate responsibility initiatives.
References
- [1] BASF Corporate Website. “Ammonium Lactate Product Portfolio.” Retrieved 2023.
- [2] Lonza Group. “Pharmaceutical Ingredients and APIs.” Product Data Sheets, 2023.
- [3] Ashland Global Holdings Inc. “Active Ingredients for Personal Care.” Corporate Overview, 2023.
- [4] Symrise AG. “Sustainable Ingredients for Pharmaceuticals.” Sustainability Report, 2023.
- [5] Tianjin Zhongxin Pharmaceutical Group Co., Ltd. Official Website. “API Production Capabilities,” 2023.
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