We treat your product as if it were our own.
We partner with pharmaceutical brands to support their encapsulation needs. Our extensive expertise, state-of-the-art equipment, and strict processes ensure precision dosing with every capsule.
An integrated team commitment to your success.
Making a Difference in the healthcare world
From brand new products to existing ones in need of new revenue streams, benefit from our years of pharmaceutical experience and let us help you get your product to market.
Capcium offers flawless technology transfer execution fostering strong customer relationships. From start to finish, Capcium understands the critical path of seamless execution that supports faster commercial launch. All managed through a GMP compliant technology transfer process with ICH quality-by-design concepts in mind, supporting swift post-approval CMC changes in the future.
- Analytical Method Transfer and Validation
- Development Trials
- Exhibit Batch Manufacturing
- Full Scale Characterization Batch
- Process Validation Batches
- Stability Studies
- Commercial Batches
Whether it is for early concept, feasibility, characterization, pre-formulation, formulation development, formulation optimization, DoE’s, process development, our dedicated formulation and process development scientists with 100+ years of cumulative experience can handle complex and diverse soft capsule formulations.
We safeguard your product supply by achieving the established quality target product profile, reducing process variability, and by consistently complying to regulated market requirements. Capcium supports development of new and generic (existing) product pipelines.
- Prescription products
- Ove-the-Counter products
- Dietary supplemen, nutraceutical products
- Cannabis products
Custom Size optionsOval, Oblong, Round
In today’s competitive market environment, Capcium has learned that improving supply chain performance is critical to maintain competitive advantages.
Forecasting, planning, procurement, financing, stock levels, and marketing strategies are some of the areas in which we have to take decisions, and balance their inter-related effects simultaneously, to achieve Capcium’s organizational goals.
Procurement at Capcium is thoroughly scrutinized, and we have become more cautious of raw material and service spending. We evaluate different suppliers, who can fulfill our requirements at a lower cost, with attention to overall spending and quality requirements.
We aim to ensure savings are measurable and sustainable – delivering greater value for Capcium over the long term.
- Security of supply key excipients
- Security of supply key ingredients
- Risk mitigation, have secondary source of supply for all key components
- Monitor market conditions, and plan buying accordingly, minimize price increase impacts
- manage on hand inventory,
- build a more reliable end-to-end Cannabis, Nutraceutical, and pharmaceutical supply chain.
Our quality team works closely with our R&D department, manufacturing and packaging operations, engineering, supply chain, vendors, and our customers to ensure we are compliant throughout the product lifecycle from development to commercialization to product discontinuation.
Our robust quality management system meets the highest regulatory standards and include management of non-conformance, CAPA, document, audit, training, complaint, compliance, change, vendor, and risk. Capcium quality control laboratory ensure that the incoming materials and final product meets the specifications set forth.
- Change control process
- Non-conformance investigation
- Corrective and preventive actions
- Document management
- Quality management system
- Audit management
- Employee training
- Vendor approval
- Tests and release of incoming raw materials
- Tests and release of in process material
- Tests and release of final product
- Tests of stability samples
Capcium is rapidly expanding its services and team to support formulation development areas.
Its fully equipped cGMP/GLP state-of-the-art laboratories provides the analytical development support for your softgel oral dose product. Method development, method validation, stabity testing, incoming raw material testing and release of final oral dose form.
- HPLC-DAD (Diode-Array Detection)
- GC-FID(flame ionization detector)-MS (Mass Spectrometer)
- ICP-MS (Inductively Coupled Plasma Mass Spectrometry)
- Spectrophotometer UV-VIS (Ultra-Violet- Visible)
- Spectrophotometer FT-IR (Fourier-Transform Infrared Spectroscopy)
- Dissolution Apparatus
- Disintegration Apparatus
- Karle Fisher Titrator & Coulometer
- Vitek (Identifications of Microorganisms)
Analytical Method Development & Method Transfer
Capcium’s analytical development team is highly experienced in supporting analytical method development or transfers suitable for assessment of the quality of products. The analytical procedures include:
- Identification tests
- Quantitative tests for impurities
- Limit tests for the control of impurities
- Quantitative tests of the active moiety or other selected component(s) in the product
Analytical Test Method Validation
Capcium’s team expertise ensures that all work is carefully planned during the test method validation process, and performs all the necessary steps providing precise, accurate and robust results specific to the dosage form.
Capcium assess the validation characteristics of accuracy, precision, repeatability, intermediate Precision, specificity, detection limit, quantitation limit, linearity, and range.
Methods are validated considering:
- ICH Harmonized Tripartite Guideline Validation of Analytical Procedures: Text and Methodology Q2(R1)
- ICH Harmonized Tripartite Guideline Analytical Procedure Development Q14
Research & Development
Capcium offer integrated end-to-end clinical to commercial stage development services. From feasibility studies, formulation development, design of experiment trials, tech transfer, scale up, to process characterization, we have the capability and knowledge to advance your discovery or idea into a commercial product for the end customer. Our fit-for-purpose phase appropriate development services cater to pharmaceutical, dietary supplement and cannabis pipelines.
Capcium maintains one of the rare soft capsule formulation development labs to support your development projects.
- Bench scale formulation equipment’s
- Fill and gel test instruments
- Pilot scale fill and gel manufacturing tanks
- Pilot scale encapsulator and tumble dryer
cGMP Manufacturing Production
- Sanitary design stainless steel gel reactors with clean in place (CIP) capabilities. The reactors are mounted on the load cells and equipped with state-of-the-art controls for the variable speed agitators, precise temperature control and vacuuming capabilities.
- Sanitary design stainless steel gel reactors with clean-in-place (CIP) capabilities. The reactors are mounted on load cells and equipped with state-of-the-art controls for the variable speed agitators and homogenizer, precise temperature control and vacuuming capabilities.
- Sanitary design gel receivers, CIP-able jacketed stainless-steel tanks with temperature control
- Sanitary design fill receivers, CIP-able stainless steel tanks.
- Gel manufacturing capacity- 6 batches per day- size/complexity dependant
- Fill manufacturing capacity 6 batches per day- size/complexity dependant
- Colloidal Mill for wet milling applications- Milling speed 200-600 kg/hr product dependant
- Deaeration- up to 600 kg/hr- product dependant.
- Polishing and printing capabilities- product dependant.
- Screens and metal detectors in process where required
- Gelatin mixing tanks 316 stainless steel
- Fill mixing tanks 316 Stainless steel
- Stainless steel Gel receivers
- Stainless steel fill receivers
Solutions for all fields of health
Capcium manufactures with industry leading safety and quality standards, we provide regulatory support for the marketed territories and for the market segment applications.
Capcium leverages ways to increase efficiency to accelerate time to market through a more collaborative, customer-focused drug life cycle. Our precision-focused, pharmaceutical-grade cGMP manufacturing operation’s agility supports the specific needs of our pharmaceutical customers.Learn more
Over the Counter (OTC)
Capcium is dedicated to developing and manufacturing name brand and non-prescription drug products in the most cost effective solutions to support the growing market demand, from pain relievers analgesics, to cough and cold medication.
Capcium’s ability to handle oils, complex pastes and size diversity formulations with no leakages, ensures that your final dose product will be compliant with all the regulations, meeting its label claim and achieve its optimal ingredient delivery.
Certifications & Compliances
Let’s discuss your project
Softgels, what we do best, our focus, our experience, your contract manufacture service provider of choice.Our Services