WHO-GMP Certified API & Pharmaceutical Intermediate Manufacturing Facility
5th Decade of Pharmaceutical Manufacturing Expertise in India
Globally Recognized Quality & Regulatory Compliance for API Manufacturing
We are WHO-GMP Certified and have Written Confirmation (WC) for export to Europe.
With regulatory approvals from Japan PMDA and European authorities.
API are manufactured as per ICH guidelines, WHO- GMP and ISO certified processes.
Our Quality Control is 21CFR Part 11 compliant.
Facility for Speciality Chemicals & Intermediates
Advanced chemical intermediates and specialty compounds designed for pharmaceutical synthesis and research applications.
Our portfolio includes complex organic molecules with precise specifications, supporting innovation in drug development and manufacturing processes worldwide.
Created dedicated facilities for specific reactions like Nitration, Oxidation, Sulfonation and Chloro - Sulfonation.
Our key to success is in synthesis of Backward and Forward integration with process optimization and improvisation.
We are a leading global provider of intermediated and speciality chemicals like Sulphonyl Chlorides, Amides, Acids and its derivates.
Trusted by Global Pharmaceutical Leaders
Production Capacity
3 streams of production line with WHO-GMP Certification
Audited Excellence
Regularly audited by top Indian and international firms
Client Growth
Exclusive supplier to Teva, Sanofi, Bayer & Lonza for 15–20 years
Watch DK PharmaChem Manufacturing Facility Video
Our Core Competences
Frequently Asked Questions
Where is DK PharmaChem's manufacturing facility located, and what does it produce?
DK PharmaChem’s manufacturing unit is located at MIDC Badlapur, Thane, Maharashtra, India. The facility produces Active Pharmaceutical Ingredients (APIs), chemical intermediates, specialty chemicals and Vitamin D3 analogues for pharmaceutical buyers worldwide. The company has more than four decades of manufacturing experience and serves both finished-dose manufacturers and research-led customers.
Is DK PharmaChem's API manufacturing facility WHO-GMP certified, and which regulatory approvals support export?
Yes. The facility is certified under WHO Good Manufacturing Practices (WHO-GMP) and holds Written Confirmation (WC) for export of APIs to Europe. DK PharmaChem also reports approvals from Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) and European authorities. APIs are made under International Council for Harmonisation (ICH) guidelines and ISO certified processes. Documentation such as Drug Master Files (DMF) or Certificates of Suitability (CEP) varies by product, so buyers should confirm the status of each molecule.
Which chemical reactions can DK PharmaChem's facility handle for intermediates and specialty chemicals?
The facility has dedicated capability for nitration, oxidation, sulfonation and chloro-sulfonation. Its core competencies also include halogenation, esterification, diazotisation, hydrogenation, reduction, ammonolysis, alkylation and Grignard reactions. This range lets DK PharmaChem supply sulfonyl chlorides, amides, acids and their derivatives. It also supports custom synthesis requests from sourcing teams.
How is the facility set up to ensure consistent, long-term supply to global buyers?
DK PharmaChem operates three production streams under WHO-GMP certification. It also follows a backward and forward integration approach, supported by process optimisation. This means key intermediates can be produced in-house rather than depending only on external suppliers, which helps with supply continuity and cost control. Batch sizes and annual capacity for a specific molecule can be shared on request.
What quality systems and data integrity controls apply at DK PharmaChem's facility?
Quality Control (QC) operations are compliant with 21 CFR Part 11, the US standard for electronic records and signatures. Manufacturing follows WHO-GMP, ICH guidelines and ISO certified processes. The facility is audited regularly by leading Indian and international companies. DK PharmaChem has supplied Teva, Sanofi, Bayer and Lonza on an exclusive basis for 15 to 20 years, which shows sustained performance under customer audits.
Does DK PharmaChem manufacture Vitamin D3 analogues, and which ones are available?
Yes. DK PharmaChem manufactures and exports Vitamin D3 analogues, including Alfacalcidol, Calcipotriol (anhydrous and monohydrate forms) and Calcitriol. These are high-potency, specialised molecules, so buyers should request specifications, stability data and the documentation package for each product before qualification.