A Portfolio Built on Strong Partnerships
Our product offerings result from strategic partnerships with a diverse suppliers and partners across China, Korea, India, and Europe, combined with a robust sourcing and qualification process. These collaborations are designed to create mutual value and leverage Molkem’s expertise to unlock new market opportunities globally.
Commitment to Quality and Compliance
All our partner production facilities adhere to the highest standards, holding certifications such as GMP, WHO-GMP, EU GMP, US FDA, and Anvisa approvals. Our products are supported by comprehensive regulatory documentation, including:
This ensures smooth regulatory filings and seamless market entry for our clients.
Molkem offers a diverse and stable product portfolio through strategic partnerships. Our contract manufacturing (CDMO) services deliver quality and innovation, underpinned by strict confidentiality agreements and collaborative engagement.
At Molkem Labs, we prioritize cutting-edge research and development. Equipped with state-of-the-art facilities, our team specializes in formulation innovation, analytical development, and tech transfers, driving solutions tailored to client needs.
Our in-house regulatory team ensures smooth product registration and compliance for both clients and partners. From resolving queries to managing complex filings, we provide end-to-end support, enabling seamless market access worldwide.
With a global footprint, Molkem serves over 60 countries through its subsidiaries (and warehouse) in Brazil, Dubai, and Vietnam, India and sales offices in Colombia, Argentina. We continue to expand into new markets, ensuring timely delivery and unmatched customer service.
Talk to our team about your current brief or upcoming launches. We’ll align on specifications, documentation, supply plans, and timelines, and execute with complete traceability from start to finish.
Access a curated portfolio of Active Pharmaceutical Ingredients (API) options sourced from audited facilities with robust quality systems. We prioritize route transparency, impurity profiles, stability data, and technology transfer support to ensure rapid onboarding into your internal QA and development workflows. Whether you require pilot quantities or commercial volumes, our team aligns on specs, CoAs, stability commitments, and shipment cadence to keep your production on schedule.
We supply pharmaceutical excipients supported by US-DMF/CEP dossiers where applicable, ensuring clean documentation trails for regulated submissions. From binders and fillers to controlled-release polymers, we match materials by grade, functionality, and excipient uses across oral solid, liquid, topical, and parenteral formulations. Each engagement is backed by change-control clarity, TSE/BSE statements, nitrosamine risk assessments where relevant, and batch-wise traceability.
Our pharmaceutical pellets offering covers sustained-release, delayed-release, and taste-masked systems ready for capsule filling or tableting. We work with specialist manufacturers for tailored particle-size distribution, coating systems, and assay uniformity. The result: shorter development cycles, consistent performance, and robust scale-up for lifecycle extensions and line expansions.
Secure pharmaceutical intermediates and advanced building blocks that meet your synthesis and lead-time constraints. We emphasise route efficiency, cost-in-use, and long-term supply security. With documented impurity control and scalable chemistry, your teams can derisk API programs while improving COGS at commercial scale.
For QC and method development, we source certified elemental impurity mixes and reference standards, including non-pharmacopeial impurities, to support method suitability, system suitability, and release testing. Full documentation packages reduce onboarding time for both development and commercial labs.
When speed to market matters, our network enables procurement or tech transfer for finished dosage formulations across solid orals, liquids, semi-solids, and select specialty forms. We align on pack formats, stability zones, and artwork readiness while ensuring market-specific regulatory pathways remain clear and timely.
We supply pharmaceutical solvent grades and catalysts meeting stringent impurity and residue specifications for GMP environments. From high-purity solvents to precious-metal catalysts, our focus is on consistency, safety data, and reliable replenishment to keep your processes running smoothly.
Molkem sources from audited, quality-driven manufacturers, including WHO-GMP, ANVISA, EU-GMP, and USFDA-approved suppliers, so you can confidently navigate agency expectations, inspections, and post-approval changes.
From gram-scale development to metric-ton shipments, we tailor supply plans to match project stage, forecast variability, and regional demand. Our flexible models help you avoid over-inventory while protecting service levels.
Supply certainty is built, not assumed. At Molkem, we maintain documented chain-of-custody, batch-level traceability, and proactive risk monitoring. Where feasible, we design multi-source supply models to strengthen reliability, while respecting project-specific regulatory and validation requirements. Each order is supported with comprehensive documentation, including CoAs, MSDS, stability data, cleaning validation summaries where applicable, and change-control notifications. This way, your QA, production, and regulatory teams stay aligned. Our logistics desk manages temperature-controlled shipments, DG handling (where relevant), and customs compliance to minimize dwell time and reduce the cost of delays.
Our in-house regulatory team ensures smooth product registration and compliance for both clients and partners. From resolving queries to managing complex filings, we provide end-to-end support, enabling seamless market access worldwide. Expect dossier gap analyses, DMF/CEP coordination, nitrosamine risk assessments where applicable, elemental-impurity mapping, and lifecycle management, so submissions progress without friction and post-approval changes remain transparent.
As a pharmaceutical CDMO partner, we support you from pre-formulation through commercial scale, working with qualified facilities for manufacturing and tech transfer. We structure engagements with clear confidentiality frameworks (NDAs, QoAs, and CDAs) and maintain collaborative working practices, including joint development plans, milestone gates, and defined tech-transfer packages. Whether you need pharmaceutical contract manufacturing support for a validated process or co-development for a new line, we tailor solutions to your risk profile, budget, and timelines.
Collaboration in practice:
Feasibility and compatibility screens
Prototype and scale-up batches
Process optimization and validation
Site selection and tech transfer
Ongoing quality, stability, and change-control governance
At Molkem, we combine global reach, technical expertise, and a strong supplier network to deliver end-to-end pharmaceutical solutions tailored to your needs.
Diverse Portfolio: From Active Pharmaceutical Ingredients (API) and pharmaceutical excipients to pharmaceutical intermediates, pharmaceutical pellets, pharmaceutical solvents, catalysts, and even finished dosage formulations, we provide a single place to scope, source, and scale.
Trusted Supplier Network: We collaborate with high-performing external suppliers and raw-material producers who meet stringent audit standards. Our model safeguards continuity while giving you room to optimize cost-in-use and lead times.
Global Pharmaceutical Distribution and Market Access: With a global footprint, Molkem serves over 60 countries through subsidiaries and warehousing in Brazil, Dubai, Vietnam, and India, and sales offices in Colombia and Argentina. Our expanding distribution network enables timely deliveries, localized support, and responsive customer service across key markets, so your products reach audiences reliably and compliantly.
End-to-End Regulatory Support: From DMF alignment and market-specific documentation to element-by-element responses on agency queries, our team stays engaged through approval and beyond.
Contract Research and Product Development (Molkem Labs): Through Molkem Labs, we provide practical, high-impact pharmaceutical product development support: formulation innovation, analytical development, method validation, and tech transfers. Equipped with modern instrumentation and supported by experienced scientists, we turn development plans into validated processes ready for commercial scale.
Molkem unifies sourcing, compliance, logistics, and pharmaceutical contract manufacturing so you can accelerate development, de-risk approvals, and scale supply with confidence. Whether you need a niche excipient for a new release profile, an intermediate for route optimization, or a turnkey tech transfer for commercial launch, we’re set up to deliver. Share your material list or development brief. We’ll propose qualified sources, documentation packs, and a supply plan aligned to your quality and timeline goals. Ready to simplify sourcing and accelerate development? Contact Molkem to align on materials, documentation, and delivery schedules that fit your roadmap.
Read morePharmaceutical CDMOs act as a bridge between clients and qualified third-party manufacturers. They help identify the right raw materials, manage technology transfer, and oversee compliance. This ensures a reliable supply without the client needing to coordinate multiple vendors directly.
Yes. Our portfolio spans APIs, pharmaceutical excipients (DMF-grade), and semi-finished options like pharmaceutical pellets, supporting rapid movement into finished dosage formulations.
Absolutely. We offer flexible volumes, from gram- and kilo-scale development to commercial shipments, so you can prototype, validate, and scale without switching suppliers.
Pharmaceutical sourcing depends on verified suppliers, audited facilities, and documented traceability. Companies often work with global distributors, like Molkem, to secure a consistent supply of APIs, excipients, and intermediates.
Global distributors typically source from WHO-GMP, USFDA, EU-GMP, and ANVISA-approved facilities. These certifications ensure compliance with international quality and regulatory standards.
Key challenges include customs delays, temperature-controlled logistics, varying regional regulations, and managing flexible volumes. A trusted pharmaceutical distribution partner, like Molkem, helps reduce these risks.
Standard packs include CoA, MSDS, TSE/BSE statements (where applicable), elemental-impurity assessments, and stability or residual-solvent data as required. Molkem also helps manage change-control communications.
Pharmaceutical CDMO partners like Molkem maintain audited supplier panels, documented chain-of-custody, and multi-source strategies. Each batch is traceable end to end, aligned with your QA and regulatory needs.
Yes. As a pharmaceutical CDMO, Molkem provides pre-formulation, prototype development, process optimization, validation, and pharmaceutical contract manufacturing through qualified sites.
Our regulatory team manages dossier gaps, DMF/CEP coordination, nitrosamine risk assessments where applicable, and Q&A responses - smoothing market entry and approvals.
We provide route-appropriate pharmaceutical intermediates, high-purity pharmaceutical solvents, and catalysts with the documentation required for GMP environments and safe handling.
At Molkem, we streamline onboarding: sign NDAs, confirm specs, align on documentation, and set a logistics plan. With existing global distribution in Brazil, Dubai, Vietnam, India, and sales presence in Colombia and Argentina, we compress timelines while maintaining compliance.
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