Pharma or Bulk Drug Chemical
Pharmaceutical APIs — Your Gateway to India
The Osiltec Chemical Industry can be simplified into two main parts – fine chemicals, which are pure and complex, and bulk chemicals, which are made in huge quantities. Fine chemicals provide the means for things like drugs, fragrances, and additives in food. Some examples of bulk chemicals are ammonia, sulfuric acid, and sodium hydroxide, which are all made at large chemical plants via a variety of different processes. There are significant differences between the two front-runners of the chemical industry.
GMP-Certified. Globally Documented. Sourced from Hyderabad — the World's Bulk Drug Capital.
India produces more than 20% of the world’s generic API volume. It supplies to over 200 countries — including the United States, Europe, Japan, and the most demanding regulated markets on the planet. Osiltec Chemicals sits at the centre of this ecosystem: headquartered in Hyderabad, Telangana, the single largest pharmaceutical manufacturing cluster in the world.
We are not a manufacturer. We are your India API desk — your sourcing partner, documentation coordinator, and supply chain bridge between the world’s best-priced, best-certified API plants and your formulation operations, wherever you are.
Why Global Pharma Companies Source APIs from India
The global pharmaceutical industry’s dependence on Indian APIs is not a trend — it is a structural reality that has been building for five decades. India’s unique combination of scale, regulatory compliance, cost efficiency, and scientific depth makes it the world’s most reliable source of generic APIs.
Scale
Quality
Cost
Trust
Indian API manufacturers hold more USFDA-approved manufacturing sites outside the United States than any other country. They supply to the generic drug industries of North America, the EU, the UK, Australia, Japan, the Middle East, Africa, and Asia — simultaneously. The depth of molecule coverage, the breadth of manufacturing capacity, and the quality of regulatory documentation from Indian plants is unmatched at this price point anywhere in the world.
For pharmaceutical companies that are currently sourcing APIs from China, Europe, or through multi-tier trading chains, India offers a powerful alternative — or a risk-diversification layer — that can reduce cost, improve documentation quality, and strengthen supply continuity.
Why Hyderabad. Why Osiltec Chemicals.
Not all of India’s pharma capacity is equal. Hyderabad is where the world’s largest and most sophisticated API manufacturing operations are concentrated — and it is where Osiltec Chemicals is based.
Being in Hyderabad is not just a geography — it is an operational advantage. Our team works within the same industrial ecosystem as the manufacturers we source from. We know which plants have capacity, which have the relevant GMP certification, which have documentation ready for regulated-market submissions, and which are performing best on quality metrics. This intelligence is not available from a desk in Singapore, Dubai, or London. It comes from being here.
| Hyderabad — India's Bulk Drug Capital | What This Means for You |
|---|---|
| 40% of India's total bulk drug production originates here | Access to the highest-density API manufacturing cluster on the planet — from a single sourcing partner |
| 50% of India's API exports leave from Telangana/AP plants | Established export logistics, competitive freight rates, and shorter lead times from factory to port |
| 200+ API manufacturing units in Telangana and Andhra Pradesh | Broad molecule coverage and multiple qualified manufacturers per API for supply continuity |
| Home to Aurobindo, Divi's Labs, Dr. Reddy's, NATCO, Granules, Mylan — world-class API makers | Our local presence means direct manufacturer relationships — not blind internet sourcing |
| Pharmexcil (India's Pharma Export Promotion Council) is headquartered in Hyderabad | We operate within the same ecosystem — government-backed pharma export infrastructure surrounds us |
What we do
What Osiltec Chemicals Does for You
We simplify India. Our clients do not need to navigate the complexity of Indian pharmaceutical supply chains, manufacturer qualification processes, export regulations, or documentation requirements. That is our job. Here is what we deliver:
Think of us as your dedicated India procurement office — without the cost of a physical operation in India. We handle everything from initial supplier identification through to post-shipment batch record management, so your team can focus on formulation, registration, and sales.
API Sourcing & Procurement
Identify, qualify, and procure GMP-certified APIs from vetted Indian manufacturers matching your molecule, grade, and regulatory requirement
Regulatory Documentation
Assemble complete documentation packages: CoA, GMP certificates, MSDS/SDS, DMF reference letters, CEP/COS, CPP, stability data — matched to your destination market's requirements
Vendor Qualification Support
Provide manufacturer audit reports, facility inspection records, and third-party QC data to support your internal vendor qualification and approved supplier list processes
Sample Procurement
Arrange reference and working samples with full analytical reports — dispatched internationally via courier from manufacturer to your QC lab
Export Logistics & Documentation
Coordinate full export documentation (Commercial Invoice, Packing List, Bill of Lading, COO), insurance, and freight forwarding — FOB Indian port or CIF destination port
Supply Planning & Continuity
Maintain supply calendars, track lead times, alert on re-test dates, and offer multi-manufacturer sourcing options to protect against single-source supply risk
New Molecule Sourcing
Source APIs not yet in our standard catalogue — leveraging our Hyderabad network and Indian manufacturer relationships to find compliant suppliers for non-standard or niche molecules
Cost Benchmarking
Provide comparative pricing from 2–3 qualified manufacturers per API to support your procurement decisions and supplier negotiation
API Portfolio — Core Supply Range
We source across all major therapeutic categories relevant to generic drug manufacturers. Our standard supply range covers high-volume commodity APIs through to specialty and oncology molecules. Every API we supply comes from a manufacturer with a current, valid GMP certification aligned to your market requirements.
Our manufacturer network covers 500+ APIs across all therapeutic areas. If your molecule is not listed here, send us an RFQ — we will source it.
| Therapeutic Category | Key APIs Available | Standards | GMP Certification Available |
|---|---|---|---|
| Cardiovascular & Metabolic | Atorvastatin, Amlodipine, Metoprolol, Ramipril, Rosuvastatin, Clopidogrel | USP / BP / EP | USFDA / EU-GMP / WHO-GMP |
| Anti-Diabetic | Metformin HCl, Glibenclamide, Sitagliptin, Vildagliptin, Glimepiride | USP / BP / IP | WHO-GMP / USFDA |
| Anti-Infective & Antibiotics | Amoxicillin, Azithromycin, Ciprofloxacin, Ceftriaxone, Doxycycline, Metronidazole | USP / BP / IP | WHO-GMP / EU-GMP |
| Analgesic & Anti-inflammatory | Paracetamol, Ibuprofen, Diclofenac Sodium, Naproxen, Meloxicam, Piroxicam | USP / BP / EP | USFDA / WHO-GMP |
| Central Nervous System | Gabapentin, Pregabalin, Sertraline, Alprazolam, Olanzapine, Levetiracetam | USP / BP | WHO-GMP / EU-GMP |
| Respiratory | Salbutamol Sulfate, Montelukast, Theophylline, Budesonide, Fluticasone Propionate | USP / BP | WHO-GMP / USFDA |
| Gastrointestinal | Omeprazole, Pantoprazole, Rabeprazole, Domperidone, Loperamide | USP / BP / IP | WHO-GMP |
| Oncology & Specialty | Capecitabine, Imatinib, Lenalidomide, Sorafenib, Erlotinib — licensed buyers | USP / EP | EU-GMP / USFDA |
| Vitamins & Nutraceutical | Ascorbic Acid, Cyanocobalamin (B12), Folic Acid, Niacinamide, Zinc Sulfate | USP / BP / FCC | WHO-GMP / Food Grade |
| Pharmaceutical Excipients | MCC, Lactose Monohydrate, PVP (Povidone), HPMC, Croscarmellose Sodium | NF / EP | WHO-GMP / EU-GMP |
Documentation — Built for Regulated Markets
A pharmaceutical API without proper documentation is a regulatory liability. Every supply from Osiltec Chemicals is backed by a complete, market-matched documentation package. We do not just ship product — we ship evidence.
Certificate of Analysis (CoA)
Certificate of Analysis (CoA)
GMP Certificate (WHO/USFDA/EU-GMP)
GMP Certificate (WHO/USFDA/EU-GMP)
MSDS / SDS (GHS-compliant)
MSDS / SDS (GHS-compliant)
Pharmacopoeial Compliance Statement
Pharmacopoeial Compliance Statement
Drug Master File (DMF) Reference Letter
Drug Master File (DMF) Reference Letter
CEP / Certificate of Suitability (EDQM)
CEP / Certificate of Suitability (EDQM)
Certificate of Pharmaceutical Product (CPP)
Certificate of Pharmaceutical Product (CPP)
Residual Solvents Report (ICH Q3C)
Residual Solvents Report (ICH Q3C)
Genotoxic Impurities / Nitrosamine Assessment
Genotoxic Impurities / Nitrosamine Assessment
Stability Data Summary
Stability Data Summary
Halal / Kosher Certification
Halal / Kosher Certification
Third-Party Lab Test Report
Third-Party Lab Test Report
Active Pharmaceutical Ingredients
Aspirin
Physical and Chemical Properties: White crystal or crystalline powder, with acid taste and is stable in dry air, slowly hydrolyze into salicylic acid and acetic anhydride. Its solution shows and acid reaction. Sparingly soluble in alcohol, chloroform or ether, slightly soluble in water or absolute ether, it dissolves in alkali hydroxide or alkali carbonate solution and decomposes at the same time.
Acetamide
Acetamide is the simplest amide derived from acetic acid. It is used as a plasticizer, wetting, penetrating agent, industrial solvent and drug intermediate.
Tryptamine
Tryptamine is a monoamine alkaloid found in plants, fungi, and animals. It is based around the indole ring structure, and is chemically related to the amino acid tryptophan, from which its name is derived. Tryptamine is found in trace amounts in the brains of mammals and is believed to play a role as a neuromodulator or neurotransmitter.
Para Nitro Toluene
Para Nitro Toluene is used for production of toluidine, fuchsin, and various synthetic dyes, bulk drug intermediate, dye intermediates, optical whitener, intermediate for explosives.
Methyl Isothiocyanate
Methyl Isothiocyanate is the organosulfur compound with low melting colorless solid. Solutions of MITC is used in agriculture as a soil fumigant, mainly for protection against fungi and nematodes and it is the building block for the synthesis of 1,3,4-thiadiazoles, which are heterocyclic compounds used as herbicides. Zantac and Tagamet also prepared from methyl isothiocyanate.
Most Reliable Chemical Supplier in India!!
We will be glad to support any client, who would like to know more or collaborate with us. Please feel free to contact us.
Regulatory Markets We Document For
Our documentation packages are prepared with the specific requirements of your destination market in mind. We regularly supply documentation aligned to:
United States
USFDA DMF (Type II) filings, 21 CFR compliance, ICH Q7 GMP
European Union
EDQM CEP/COS, EDMF, EU-GMP certificates, ICH guidelines
United Kingdom
MHRA-compliant documentation post-Brexit
Australia
TGA-aligned documentation, Therapeutic Goods Act requirements
Southeast Asia & ASEAN
country-specific pharmacopoeial standards and import documentation
Middle East (GCC)
SFDA, MOH-UAE, Kuwait CAPA, and other Gulf authority requirements
Africa & CIS
WHO-GMP certified supply with simplified but complete documentation packages
Documentation — Built for Regulated Markets
India
India API sourcing, qualification & export — Osiltec Chemicals, Hyderabad
Singapore
Singapore trading and re-export — MFF International Pte Ltd
Indonesia
Indonesia distribution and regulatory support — MFF Chemicals
UAE
UAE and Middle East supply — VMV Solutions / MFF International
Part of a Wider International Network
Osiltec Chemicals is the India API origination arm of a broader international chemicals and industrial supply group with operations across Singapore, Indonesia, India, and the UAE. Our sister entities — including MFF Chemicals (Indonesia) and MFF International (Singapore) — handle downstream distribution, local registration support, and in-market logistics in key emerging markets.
This means that for clients who need end-to-end support — from Indian API sourcing through to in-country distribution and registration in Southeast Asia — our group can provide it as a joined-up service.
RFQ to delivery, with a single point of contact.
Typical timelines: Sampling — 7 to 14 business days from RFQ to courier dispatch. Commercial first order — 5 to 7 weeks from PO confirmation to vessel departure. Repeat orders with approved manufacturers — 3 to 5 weeks.
Submit RFQ
API name, grade, pharmacopoeial standard, quantity, destination market, and any regulatory constraints.
Supplier Match
We match to 2–3 qualified manufacturers after reviewing GMP capability and documentation.
Quotation + Docs
Competitive FOB/CIF pricing, estimated lead time, and documentation availability.
Sample & QC
Samples supplied with CoA for customer evaluation against internal quality requirements.
Commercial Order
Purchase Order confirmation, production planning, and manufacturing schedule.
Ship & Support
Export documentation, freight coordination, shipment tracking, and after-sales support.
We reply to every RFQ within 1 business day.
Choose the channel that works best for your team:
Request a quotation
Email:
Osiltec Chemicals | Pharma API Division
NEXUS BUSINESS CENTRE, Mega Hills, Madhapur, Hyderabad 500081, Telangana, India