FAQs - Questions We Expect From Serious Partners

Lead Times
Our standard lead time is 45-60 days from order confirmation. This timeline is structured, not arbitrary; it exists to protect the integrity of your product.

The breakdown is as follows:

• Raw material procurement and vendor lead times: approximately 25 days
• Packaging material procurement: approximately 30 days
• Manufacturing, in-process quality checks, and pharmacopoeial testing: 10-15 days

Manufacturers who promise 30-40 day delivery are typically cutting corners on raw material quality, sourcing or bypassing standard testing protocols. We do not compromise on either. Our 45-60 day timeline guarantees batch integrity and full regulatory compliance.

Process
Once we receive your enquiry, a dedicated account manager will reach out within 1-2 working days to understand your requirements. From there, our process follows these stages:

• Formulation selection or development discussion
• Quotation and commercial alignment
• Purchase order and advance payment confirmation
• Raw material and packaging material procurement
• Manufacturing, QC testing, and batch release
• Dispatch and documentation handover

You will have a single point of contact throughout the engagement to ensure continuity and clear communication.

Scheduling
We understand that business situations sometimes demand faster turnarounds. Where raw materials and packaging are already available in our inventory, such as for repeat orders of existing formulations, timelines can be compressed significantly.

For new product requests, a 45-60 day window is required to maintain quality standards. Please discuss your timeline constraints with your account manager at the outset so we can plan accordingly and set accurate expectations.

R&D & Evidence
Clinical studies are available for the individual ingredients within our formulations. For completely finished formulations, we maintain comprehensive stability data and analytical documentation based on validated formulation science.

For our proprietary formulations: Ostizeel™, CephaMig™, and PEAvision™, preclinical studies are complete, and clinical trials are in the pipeline. With 9 PCT patent applications filed, these represent our most advanced innovation work.

Across our broader portfolio, conducting product-specific clinical trials for every formulation is not standard practice in the industry. We will share all available ingredient-level clinical references and formulation-specific stability data as part of our documentation package.

Documentation
Every batch dispatched from Makin comes with a full documentation package, including:

• Certificate of Analysis (CoA) from our in-house QC laboratory
• Manufacturing licence
• WHO-GMP certification copies (for regulatory submissions)

For export batches, we can additionally provide documentation required for international regulatory submissions, depending on the target market.

Facility Audit
Yes, and we actively welcome it. Client audits are a standard part of our vendor qualification process and reflect the seriousness with which we treat quality assurance. You are welcome to schedule a facility visit to review our manufacturing setup, QC laboratory, documentation systems, and SOPs.

Please contact us at partnership@makinlaboratories.com to arrange an audit visit. We will coordinate with your quality team to ensure the audit covers all areas relevant to your assessment.

Samples
We provide R&D batch samples accompanied by full documentation, including R&D batch Certificates of Analysis, stability data, and analytical reports meeting all applicable regulatory requirements.

These documentation packages serve commercial evaluation purposes with complete traceability and are accepted by regulatory authorities and procurement teams as valid pre-commercial evidence. If you have specific documentation requirements, please share them with us at the outset so we can align our sample package accordingly.

MOQ
MOQ at Makin is determined by the dosage form, raw material procurement thresholds, and batch size requirements, not by an arbitrary commercial policy. Manufacturing smaller-than-minimum batches risks formulation inconsistency and is not aligned with GMP standards.

For most solid dosage forms (tablets, capsules), the standard MOQ is discussed during the enquiry stage based on your specific product and volume projections. We encourage a transparent conversation about your annual volume requirements so we can propose the most practical and cost-effective arrangement.

For new partnerships, we are open to discussing flexible first-order structures where appropriate.

Payment
For new partnerships, our standard policy requires advance payment for the first three orders. This is a mutual trust-building measure, not a reflection of distrust, but of establishing the operational and financial foundation for a long-term relationship. It is standard practice across the contract manufacturing industry.

Following the completion of three successful orders, we extend credit facilities supported by appropriate instruments, in line with our credit policy. We are happy to discuss the specifics during commercial discussions.

Inventory
Inventory charges at Makin reflect the actual cost of procuring raw materials and packaging materials from validated vendors, not a margin addition on our end. Our packaging material vendors operate with minimum order quantities of their own, which must be met to secure the materials at verified quality levels.

Where quantities procured exceed what is consumed in a single batch, the remaining inventory is held for your subsequent orders and effectively reduces your per-unit material cost over a 2-3 order cycle. We are happy to provide a detailed inventory cost breakdown on request.

Alternate Vendor
Absolutely. Vendor loyalty is a sign of good business practice, and we respect it. However, most serious organisations develop alternate vendor relationships for supply chain resilience and product portfolio expansion.

We are often approached for alternate vendor development or for new product launches that don't disrupt existing manufacturing relationships. If you have a new therapeutic area or formulation category you are exploring, we would welcome a conversation to see whether Makin is a complementary fit.

Custom Formulation
Both. Our in-house R&D team can develop fully custom formulations aligned to your brand strategy, target consumer, and therapeutic positioning from ingredient selection through to dosage form, strength optimisation, and stability validation.

We also maintain a library of market-ready formulations for partners who want to move quickly to market without a full development cycle. With over 2,500 SKUs in our portfolio, there is a strong likelihood we have an existing formulation that closely aligns with your requirements.

If you are looking for innovation that goes beyond standard catalogue offerings, including first-in-category formulations, please reach out to discuss your brief with our formulation team.

Exclusivity
Yes, exclusivity arrangements are available for partners who can commit to defined volume thresholds. Exclusivity is structured around the formulation, brand, and territory, and is formalised through a commercial agreement.

If exclusivity is a requirement for your business, we recommend discussing this early in the conversation so commercial terms can be aligned correctly from the outset.

Export & Regulatory
Yes. We currently export to over 25 countries and have established experience supporting the regulatory documentation requirements of international markets. This includes stability data, Certificate of Analysis, WHO-GMP certification copies, product dossiers, and other documentation commonly required for registration in export markets.

Each target market has specific requirements. We recommend sharing your export destinations early, so our regulatory and documentation team can assess what is needed and structure the manufacturing and documentation process accordingly.