Facility
Graminex is the exclusive manufacturer of Graminex ™ Flower Pollen
Extract in the United States. The Corporate
headquarters are located in
Saginaw, Michigan. Utilizing state of the art
science and technology, Graminex offers the highest quality botanical products available
in the marketplace.
Graminex has several facilities and experienced personnel to
develop a variety of botanical products, including powdered, standardized extracts, and
simple drug ratio extracts. Graminex has more than 10,000 acres available for medicinal
plants. There are few companies in the world that can have, under strict supervision, the
total cycle of the medicinal plant process. Graminex starts with certified seed, uses no
herbicide or pesticides, and finishes with special patented harvester equipment. Final
processing is completed in our ISO Q9001-2000 and G.M.P. certified facility.
Because Graminex is a contract manufacturer, equipment to
perform a multitude of functions has been developed. Our diverse equipment permits
modifying the operating conditions of the manufacturing process to meet customer demand.
The new manufacturing plant in Deshler, Ohio consists of 75,000 square feet of
manufacturing and 250,000 cubic feet of warehousing. Graminex recently completed a new
60,000 square foot facility at the Deshler site to better service our customers.
Graminex operates in the bulk botanical market specializing
in Graminex ™ Flower Pollen Extract, Fabales Red Clover Extract and granulated
Alfalfa, providing supplement manufacturers with bulk raw materials, standardized extracts
and service. Graminex strives to provide its customers with the best quality at the most
competitive price. Botanical pharmaceutical products include natural compounds used in
various drug development and commercial applications.
Manufacturing
Graminex's products are manufactured to stringent GMP guidelines. Graminex's GMP experience includes
manufacturing products for the pharmaceutical and dietary supplement industries. Graminex
specializes in Graminex ™ Flower Pollen Extract, Fabales Red Clover Extract holding 18%
isoflavones and granulated Alfalfa. To assure that the marker compound concentration in
the product meets Graminex's specifications, Graminex monitors the stability of each
product
in a pharmaceutical quality program. Graminex strives to deliver the highest level of
customer satisfaction by assisting in the implementation of analytical methods and by the
customization of products to fulfill the customers' requirements and expectations.
Graminex has developed numerous proprietary-manufacturing
technologies to process raw materials and produce specialized botanical products.
Graminex's expertise in analyzing, identifying, and measuring
low concentration compounds (occurring in starting materials), is vital to raw material
analysis, process development and quality control. Graminex designs particular
applications for manufacturing. This involves selecting the most appropriate growing,
harvesting, and processing steps, determining the proper sequence, establishing optimum
temperature, pressure, solvent and other parameters. Graminex develops variations of its
processes based on the nature of the raw materials used and the specifications of the
desired product. Because Graminex is a custom botanical and pharmaceutical manufacturer,
Graminex is not only inspected by the applicable regulatory agencies, but by the customers
themselves. Graminex's customers come from many different enforcement districts of the
Health Authorities, which gives Graminex an overall picture of GMP trends and changes in
GMP technology around the world.
Products
Graminex is dedicated to strict GMP compliance in product manufacturing. All products
such as our Graminex ™ Flower Pollen Extract, Fabales Red Clover Extract and
granulated Alfalfa are manufactured under pharmaceutical standards. A continuing
employee-training program, equipment/process validation, a Drug Master File and a
self-inspection program are part of Graminex's product
quality assurance. Validations are designed to qualify new equipment and to
evaluate/re-qualify existing equipment that has been modified. Plant inspection,
environmental monitoring, action reviews, production record format review and approval of
all Standard Operating Procedures are QA functions, which assure production standards.
Documentation for Graminex ™ Flower Pollen Extract, Fabales Red Clover,
granulated Alfalfa and other products can be supplied including in some cases
DMF's.
Remember- Graminex has the capability to produce and develop
all types of botanical products, including powdered, standardized extracts and simple drug
ratio extracts. Total flexibility and the ability to customize products to meet your
company's unique requirements is how Graminex operates and delivers.
Most of our products are kept in our warehouse, ready to
be shipped. Call us and we will ship your order to you. There are few companies in the
world that can have this kind of pharmaceutical plant process cycle under such strict
supervision.
Graminex provides botanical products with the degree of
superiority you expect and deserve. All of these factors will lead Graminex to become
"Your Botanical Source" .
Our Development
Department
- Develops and applies analytic techniques for measuring
concentrations of active ingredients.
- Establishes formulation guidelines, precautions and controls
that provide for versatility in the manufacture process.
- Performs stability studies in a controlled surveillance
facility to establish product shelf life and expiration dating.
- Establishes physical-chemical limitations such as temperature,
time, light, mixing and atmospheric restrictions for bulk solutions and/or final precuts.
- Establishes validation procedures for ingredients, methods and
processes.
- Evaluates container/closure systems to select those best
suited as determined by product compatibility.
Graminex manufactures natural prescription
drugs for foreign markets. With support from experienced pharmaceutical management and
scientists at its corporate partners, Graminex also has the capability to file IND's for botanical
products.
Development, Formulation, Quality Control and Production
Departments, work closely together to design techniques modifying equipment to eliminate
problems. The result is a better quality product, minimal manufacturing problems and
higher and consistent product yield for our customers.
Complete Quality Control
Testing and Batch Documentation
Graminex has
competent personnel to control testing of products manufactured.
Tests currently performed include:
- Wet chemical
- Instrumental analysis
- High performance Liquid Chromatography (including variable
wavelength UV and refraction index detection).
- Particulate Testing (Microscopic and HIAC)
- Chemical identification
- Paper and Thin-Layer Chromatography
- Karl Fischer Moisture Analysis
- Polarimetry (optical rotation)
Some of the Microbiological Testing and Services
Include:
- Microbial Limits Testing
- Sterility Testing
- Bioburden Studied
- Microorganism Identification
- Environmental Monitoring Program
- Particle Sizing, Enumeration and Identification
Our Mission Statement:
Graminex L.L.C. will supply the highest quality
botanicals on time to the exact specifications of each and every customer.
Since its beginning, Graminex has been involved
in the development and manufacture of a wide variety of botanical products including
Flower Pollen Extract, Fabales Red Clover Extract and granulated
Alfalfa. Graminex has become the most
experienced custom manufacturer of botanical products in the U.S. With the new
manufacturing plant in Ohio, Graminex has become one of the largest botanical companies in
the U.S. We have a history of excellence with numerous well-known satisfied customers.
Many of our customers have returned to Graminex for other products in addition to
their original requirements.Choose
Graminex for Your Botanical Source .
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