Pharmaceutical Excipients
Manufacturer Since 1982
Premier WHO-GMP certified manufacturer and exporter of pharmaceutical excipients, food ingredients, and industrial materials — trusted by 1000+ clients across 50+ countries.
Pharmaceutical Excipients, Food & Industrial Ingredients
From pharma-grade excipients to specialty food ingredients and industrial materials — precision-manufactured to the highest international standards.
Four Decades of Pharmaceutical Leadership
Founded in 1982 and headquartered in Pune, Maharashtra, Maple Biotech Pvt. Ltd. has grown into a globally respected name in specialty chemicals. We manufacture and supply over 100 high-quality products to pharmaceutical, food, and industrial sectors across 50+ countries — underpinned by rigorous quality systems and a relentless drive for innovation. Learn more about our company or get in touch with our team.
Internationally Certified & Compliant
Our products and processes are validated against the most stringent global standards — giving you complete confidence in every shipment.
Reaching 50+ Countries Worldwide
From Asia-Pacific to the Americas, Maple Biotech's products are trusted by leading pharmaceutical manufacturers, food processors, and industrial companies worldwide.
India's Premier Pharmaceutical Excipients Manufacturer
For over four decades, Maple Biotech has been the trusted source for pharmaceutical excipients, food ingredients, and specialty materials — combining rigorous quality, deep technical expertise, and reliable global supply.
Full-Range Excipient Portfolio
Our pharmaceutical excipient portfolio spans all major functional categories: diluents and binders (Microcrystalline Cellulose grades MCC PH-101 through PH-200, Pregelatinized Starch), disintegrants (Sodium Starch Glycolate, Croscarmellose Sodium, Crospovidone Type A and B), flow aids (Colloidal Silicon Dioxide, Magnesium Stearate, Calcium Stearate), and polymers (Povidone PVP K30 and K90, Sodium CMC). All products comply with USP/NF, EP, IP, and JP monographs.
Regulatory-Ready Documentation
Every pharmaceutical excipient from Maple Biotech is supported by comprehensive regulatory documentation: US Drug Master Files (US-DMF), Certificates of Analysis (CoA), Material Safety Data Sheets (MSDS/SDS), BSE/TSE declarations, and Allergen statements. Our WHO-GMP certificate and US-DMF enable customers to register drug products in FDA-regulated (USA), EMA-regulated (EU), PMDA-regulated (Japan), and ICH-harmonised markets worldwide.
Direct Compression & Co-processed Excipients
Maple Biotech specialises in direct compression pharmaceutical excipients that eliminate costly granulation steps. Our co-processed range — AMBI-CELACT (MCC + Lactose Monohydrate 75:25), AMBI-GG (MCC + Guar Gum for sustained release), and AMBI-TCP (MCC + Tricalcium Phosphate for calcium supplement tablets) — delivers superior flowability and compressibility versus single-component materials, reducing tablet manufacturing time and cost.
Reliable Global Export Supply
With established logistics to 50+ countries including the USA, Germany, UK, France, UAE, Saudi Arabia, Brazil, Vietnam, Indonesia, Kenya, and South Africa, Maple Biotech delivers pharmaceutical excipients by FCL containers, LCL, and air freight. Our Pune MIDC Bhosari facility maintains bonded warehouse stock for rapid dispatch, with Certificate of Origin, Phytosanitary, and fumigation certificates provided as standard for all export shipments.
Everything You Need to Know About Maple Biotech Excipients
Get answers to the most common questions about our pharmaceutical excipients, certifications, export capabilities, and how to request samples, COA, and quotations.
What pharmaceutical excipients does Maple Biotech manufacture?
Maple Biotech manufactures 48+ pharmaceutical excipients including Microcrystalline Cellulose (AMBICEL MCC 101, 102, 112, 200, 301, 302), Sodium Starch Glycolate (CELTAB), Croscarmellose Sodium (CEL-CA-DISSOL), Crospovidone (CRODIS XL-10 A/B), Povidone PVP K30 & K90 (POVIMINE), Pregelatinized Starch (MABITAB 1500/3000), Magnesium Stearate (STEARION), Calcium Stearate (STEAREX), Sodium CMC (CARBOGENIX), Colloidal Silicon Dioxide (COSILIFLOXA), and co-processed excipients. All products meet USP/NF, EP, IP, and JP pharmacopoeia standards.
What Microcrystalline Cellulose (MCC) grades does Maple Biotech offer?
Maple Biotech manufactures 6 standard MCC grades under the AMBICEL brand: MCC PH-101 (~50 µm standard), MCC PH-102 (~90 µm high-flow), MCC PH-112 (Silicified MCC 90 µm), MCC PH-200 (~180 µm spheronisation grade), MCC PH-301 and MCC PH-302 (Silicified). Additional specialty MCC grades include AMB-MYL MBC 581, 591, 611, and 811 for suspension and veterinary use. All grades are US-DMF listed and comply with USP/NF, EP, IP, and JP monographs.
Is Maple Biotech WHO-GMP and ISO certified?
Yes. Maple Biotech Pvt. Ltd. holds WHO-GMP, ISO 9001:2015, ISO 14001:2015, ISO 22000:2018, ISO 45001:2018, FSSC 22000, FSSAI, HALAL, and KOSHER certifications. The company holds Maharashtra Drug Licence 25-MH/101888 and active US Drug Master Files (US-DMF) for export to USA, EU, UK, Canada, Australia, and other regulated markets.
Which countries does Maple Biotech export pharmaceutical excipients to?
Maple Biotech exports to 75+ countries across Asia-Pacific, Europe, Africa, the Middle East, and the Americas. Key markets include USA, UK, Germany, France, Netherlands, Italy, Brazil, Mexico, Colombia, Argentina, UAE, Saudi Arabia, Egypt, Kenya, Nigeria, South Africa, Vietnam, Indonesia, Malaysia, Thailand, Philippines, Japan, South Korea, Taiwan, Australia, and New Zealand. Exporting since 1982 with established freight partnerships.
What food ingredients does Maple Biotech supply?
Maple Biotech supplies ISO 22000 and FSSAI certified food ingredients including Pregelatinized Maize Starch (MABITAB), Pregelatinized Potato Starch (MABITAB-P), Tamarind Seed Gum / Tamarind Kernel Powder (TAMGUM — natural guar gum alternative), Food Grade Pectin HM & LM (MAPECTIN, E440), Native Potato Starch (AMYLATO), Native Maize Starch (AMYLAIZE), Aloe Vera Juice (ALOIE), and Cellulose Dietary Fibre (CELLUCORE). All are HALAL and KOSHER certified.
How can I request a sample or quotation from Maple Biotech?
Request a free sample, price quotation, COA, or TDS by filling the Quote Request form on our website, emailing sales@maplebiotech.co.in, or WhatsApp/calling +91 8669959208. Maple Biotech typically responds within 24 hours with technical data sheets, MSDS, and pricing.
What co-processed excipients does Maple Biotech manufacture?
Maple Biotech offers three co-processed pharmaceutical excipients for direct compression: AMBI-CELACT (MCC + Lactose Monohydrate 75:25) for superior compressibility; AMBI-GG (MCC + Guar Gum) for hydrophilic sustained-release matrix tablets; and AMBI-TCP (MCC + Tricalcium Phosphate) for calcium supplement tablets combining excipient functionality with active ingredient benefits in a single directly compressible material.
Where is Maple Biotech located and how long have they been manufacturing?
Maple Biotech Pvt. Ltd. is located at J-253, MIDC Bhosari, Pune, Maharashtra – 411026, India. Founded in 1982, we have over 42 years of experience in pharmaceutical excipient and food ingredient manufacturing. The WHO-GMP certified facility operates multiple production lines in Pune's premier pharmaceutical industrial zone. The company employs 100–500 qualified professionals across production, QA, R&D, and global sales functions.
Does Maple Biotech hold a US Drug Master File (US-DMF)?
Yes. Maple Biotech holds active US Drug Master Files (Type IV — Excipient DMFs) filed with the US FDA. These DMF filings allow pharmaceutical companies in the USA to reference Maple Biotech's excipients in their New Drug Applications (NDA), Abbreviated NDA (ANDA), and other regulatory submissions without disclosing confidential manufacturing information. Letters of Access (LOA) are provided upon request.
What is Sodium Starch Glycolate (SSG) and what is CELTAB?
Sodium Starch Glycolate (SSG) is a superdisintegrant used in tablet and capsule formulations to promote rapid disintegration and drug dissolution. CELTAB is Maple Biotech's proprietary brand of SSG manufactured at their WHO-GMP Pune facility. It is available in Type A (potato starch base) and Type B (maize starch base) and complies with USP/NF, EP, and IP pharmacopoeia. CELTAB is widely used in immediate-release solid dosage forms.
What is Croscarmellose Sodium and what is CEL-CA-DISSOL?
Croscarmellose Sodium (CCS) is a cross-linked sodium carboxymethylcellulose used as a superdisintegrant in oral pharmaceutical formulations, providing rapid tablet disintegration and dissolution enhancement. CEL-CA-DISSOL is Maple Biotech's brand of pharmaceutical-grade CCS, meeting USP/NF, EP, and IP specifications. It is compatible with both direct compression and wet granulation manufacturing processes for solid dosage forms.
What is the minimum order quantity (MOQ) for pharmaceutical excipients?
Maple Biotech offers flexible MOQs tailored to customer requirements. Sample quantities (1–5 kg) are available for qualification and development trials. Commercial orders are available from 25 kg bags to full FCL container loads (typically 15–20 MT). MOQs vary by product and market. Contact our sales team at sales@maplebiotech.co.in for specific product MOQ details and volume pricing.
What certifications does Maple Biotech hold?
Maple Biotech holds: WHO-GMP (pharmaceutical manufacturing), ISO 9001:2015 (quality management), ISO 14001:2015 (environmental management), ISO 22000:2018 (food safety management), ISO 45001:2018 (occupational health & safety), FSSC 22000 (food safety system certification), FSSAI (India food licence), HALAL, KOSHER, and Maharashtra Drug Licence 25-MH/101888. All certifications are current and available for download on request.
What are direct compression (DC) pharmaceutical excipients?
Direct compression excipients are materials with inherent flowability and compressibility enabling tablet manufacture without wet or dry granulation steps. Maple Biotech's DC-grade excipients include AMBICEL MCC 102 (PH-102), AMBICEL MCC 112 (Silicified MCC), co-processed AMBI-CELACT, and MABITAB Pregelatinized Starch. These reduce manufacturing time, energy costs, and API degradation risk — making them preferred for moisture-sensitive and heat-sensitive active pharmaceutical ingredients.
What is Pregelatinized Starch and what is MABITAB?
Pregelatinized Starch is a modified starch (maize or potato) that has been partially or fully gelatinized, giving it excellent flowability, compressibility, and self-binding properties for direct compression tablet manufacturing. MABITAB 1500 (partially pregelatinized maize starch) and MABITAB 3000 (fully pregelatinized) are Maple Biotech's brands, meeting USP/NF and EP standards. MABITAB is widely used in nutritional supplements, nutraceuticals, and pharmaceutical tablets.
What is Povidone (PVP) and which grades does Maple Biotech offer?
Povidone (Polyvinylpyrrolidone, PVP) is a synthetic polymer used as a tablet binder, film-forming agent, and solubiliser in pharmaceutical formulations. POVIMINE K30 (MW ~40,000, for wet granulation and solutions) and POVIMINE K90 (MW ~1,000,000, for sustained-release and film coating) are Maple Biotech's grades, meeting USP/NF, EP, IP, and JP specifications. Both are available in pharmaceutical and food grades, HALAL and KOSHER certified, with full regulatory documentation.
What is the typical delivery time for export orders?
Standard lead times for commercial orders: 2–4 weeks for stocked products (sea freight), 3–5 days for samples and urgent orders (air freight). Sea freight transit times vary by destination: 15–25 days to Europe/USA, 7–14 days to Middle East & Africa, 5–10 days to South/Southeast Asia. Maple Biotech maintains bonded warehouse stock at Pune MIDC Bhosari for rapid dispatch. All export orders include Certificate of Origin (CO), phytosanitary, fumigation certificate, commercial invoice, and packing list.
Does Maple Biotech provide technical support and formulation assistance?
Yes. Maple Biotech's R&D and applications team provides technical support including excipient selection guidance, formulation development assistance, compatibility studies, and troubleshooting for tablet, capsule, and powder formulations. Our technical team can assist with direct compression optimization, disintegrant selection, binder level optimization, and regulatory documentation review. Technical support is available at no additional cost for qualified customers.
What regulatory documents does Maple Biotech provide with each order?
Maple Biotech provides a comprehensive regulatory document package with each order: Certificate of Analysis (COA), Technical Data Sheet (TDS), Material Safety Data Sheet (MSDS/SDS), BSE/TSE declaration, Allergen declaration, GMO statement, Certificate of Origin, HALAL and KOSHER certificates, WHO-GMP certificate, and US-DMF reference letter (where applicable). EU Reach compliance documentation and excipient CEP (Certificate of Suitability) support available on request.
What is Tamarind Seed Gum (TAMGUM) and what are its applications?
Tamarind Seed Gum (also called Tamarind Kernel Powder or TKP) is a natural polysaccharide derived from the seeds of the tamarind tree (Tamarindus indica). TAMGUM by Maple Biotech is a sustainable, non-GMO, HALAL and KOSHER certified alternative to guar gum and xanthan gum. Applications include food thickening and stabilisation, textile sizing, paper coating, pharmaceutical tablet binder, and controlled-release excipient. Exported to 40+ countries from India.
Have more questions? Contact our technical team or explore our full product catalogue.
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