Active Pharmaceutical Ingredients - API
Manufacturer & Exporter of APIs - Serving Globally
Active Pharmaceutical Ingredients (APIs)
Comprehensive range of high-quality APIs for global pharmaceutical manufacturing
| Product Name | Pharmacopoeia | CAS No. | Therapeutic Application | DMF Status |
|---|---|---|---|---|
| Buclizine Hydrochloride | BP/IP | 129-74-8 | Anti-Emetic | TFDA |
| Chloramine T | BP/EP | 7080-50-4 | Disinfectant | CEP (EDQM), AIFA |
| Dobutamine Hydrochloride | BP/EP/USP/IP | 49745-95-1 | Inotropic Agents | ODMF |
| Dopamine Hydrochloride | BP/EP/USP/IP | 62-31-7 | Inotropic Agents | CEP (EDQM), SFDA, China IDL |
| Fenofibrate | IP/BP/EP/USP | 49562-28-9 | Lipid Lowering Agent | CEP (EDQM), SFDA |
| Furosemide | BP/EP/USP/JP | 54-31-9 | Diuretic | ODMF |
| Hydralazine Hydrochloride | IP/EP/BP/USP | 304-20-1 | Anti-Hypertensive | *CEP (EDQM), Ethiopia, Tanzania, HAS, KEMSA |
| Hydroxyzine Hydrochloride | BP/EP/IP/USP | 2192-20-3 | Anti-Histamine | *CEP (EDQM), IRAN, ODMF |
| Itopride Hydrochloride | In-House | 122892-31-3 | Anti-Spasmodic | *CEP (EDQM), KDMF |
| Meclizine Hydrochloride | BP/EP/IP/USP | 1104-22-9 | Anti-Emetic | *CEP (EDQM), ODMF |
| Mesalamine / Mesalazine | BP/EP/IP/USP | 89-57-6 | Anti-Inflammatory | *CEP (EDQM), ODMF |
| Probenecid | BP/CP/EP/JP/USP | 57-66-9 | Uricosuric | CEP (EDQM), JPDMF, TGA, SAHPRA, MEDSAFE, China NMPA |
| Propofol | BP/EP/IP/USP | 2078-54-8 | General Anesthetic | ODMF |
| Trimethobenzamide Hydrochloride | USP/IP | 554-92-7 | Anti-Emetic | ODMF |
FAQ's
1. What is the difference between an API manufacturer and a supplier or trader?
An API manufacturer produces the active ingredient directly, controlling the synthesis process, quality systems, and regulatory documentation. A supplier or trader typically sources APIs from manufacturers and resells them – often without direct control over production quality or the ability to provide manufacturing-level documentation such as DMFs or CEPs. When sourcing for regulated markets, working directly with a manufacturer eliminates an intermediary layer and gives you clearer accountability on quality and compliance.
2. What certifications should a pharmaceutical API manufacturer have?
At minimum, look for WHO-GMP and ISO certification. Depending on your target market, additional certifications or regulatory approvals from bodies such as the US FDA, European authorities, or Japan’s PMDA may also be required. DK Pharmachem holds WHO-GMP and ISO certifications and has been audited by leading international quality assurance firms. Always request current certificates rather than relying on website claims alone.
3. Which countries does DK Pharmachem export APIs to?
DK Pharmachem exports to regulated and semi-regulated markets across Asia, Europe, Latin America, and the Middle East. Recognised as a Two Star Export House by the Directorate General of Foreign Trade (DGFT), India, with compliance aligned to WHO, ICH, and pharmacopoeial standards across multiple markets. For confirmation of export history to your specific country or region, contact our team directly.
4. What are the minimum order quantities for API sourcing?
Minimum order quantities vary by product and grade. DK Pharmachem works with both development-stage requirements and commercial-scale orders. To discuss MOQs for a specific API, share your product name, required grade, and approximate quantity with our team and we will revert with product-specific details.
5. How do I request a sample or trial batch before placing a commercial order?
Sample requests can be initiated by contacting DK Pharmachem’s API team with the product name, pharmacopoeial grade (USP, EP, BP, JP, or IP), and required quantity. Samples are dispatched with a Certificate of Analysis and relevant technical documentation. This is the standard first step before supplier qualification and commercial discussions.
6. What are typical lead times for orders and sample requests?
Lead times depend on the specific API, order volume, and current production schedules. DK Pharmachem’s backward and forward integration across intermediate and API production gives it greater control over lead times compared to manufacturers dependent on third-party intermediate suppliers. Indicative timelines are shared at the enquiry stage once product and quantity details are confirmed.
7. Can we conduct a facility audit or quality inspection before supplier qualification?
Yes. DK Pharmachem welcomes facility audits from prospective buyers as part of the supplier qualification process. The manufacturing facility is regularly audited by leading Indian and international pharmaceutical companies and quality assurance firms. Audit requests can be coordinated through our quality and business development teams.
8. What is a DMF or CEP and why does it matter when selecting an API manufacturer?
A Drug Master File (DMF) or Certificate of Suitability (CEP) is documentation submitted to regulatory authorities describing an API’s manufacturing process, quality controls, and specifications. If a manufacturer already holds a DMF or CEP for the API you require, your regulatory filing process is faster since much of the required technical documentation already exists. Confirm DMF and CEP status for specific APIs directly with our regulatory team.
9. Can you supply APIs to specific pharmacopoeia grades such as USP, EP, BP, or JP?
Yes. DK Pharmachem manufactures APIs to multiple pharmacopoeial standards including USP, EP, BP, JP, and IP, depending on the product. Where custom synthesis or non-standard specifications are required, our R&D and manufacturing teams can assess feasibility. Grade availability for a specific product is confirmed at the enquiry stage.
10. What documentation is provided with each API order?
Every order is accompanied by a Certificate of Analysis (CoA) for the specific batch. Additional documentation – including stability data, validation reports, GMP and ISO certificates, and DMF or CEP references where applicable – can be provided based on your regulatory requirements. A documentation checklist can be shared in advance so there are no gaps at the qualification or order stage.
11. How do I get a quote or pricing for a specific API?
Share the API name, required pharmacopoeial grade, quantity, and target market with our team at dkc@dkpharmachem.com. We will revert with pricing, lead time, and available documentation within a defined timeline. For multiple APIs or ongoing supply requirements, a consolidated enquiry helps us provide a more complete commercial proposal.
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