Pharmaceutical Excipients andContract Manufacturing

A Look to the Future!

Excipient Manufacturing Unit Production, warehouse, administration, QC labs, R&D labs, 45,000 sq. meters (485,000 sq. ft.) land, and 16,500 sq. meters (180,000 sq. ft) constructed area. Located 40 km from São Paulo City. Itapevi - São Paulo - Brazil.

Headquarters & Contract Manufacturing Unit Commercial and �nancial areas, technical assistance labs and contract manufacturing, 7,400 sq. meters (79,800 sq. ft.) land, and 6,000 sq. meters (64,900 sq. ft.) constructed area. Located 25 km from São Paulo City. Taboão da Serra - São Paulo - Brazil.

The 1990´s brought increased globalization and

placed tremendous pressure on companies to

compete globally. Blanver was ISO certi�ed

during that period and has been re-certi�ed four

times afterwards. The o�er of new solutions,

applications and products has been and will

continue to be Blanver´s commitment to

customers in more than 100 countries. A highly

service-oriented approach continues to guide

new generations of ventures and successful

partnerships with customers.

Blanver’s facilities are periodically audited by the Brazilian

Agencies, customers and independent auditing companies

such as TÜV NORD Certi�cation Body from Germany, who

issues the certi�cate and monitors the compliance with

ISO 9001.

Regulations and Standards

All Blanver’s products are manufactured in accordance with the International Good Manufacturing Practices and comply with the most used compendia such as:

Yearly updates in the format of certi�cates and statements are provided to customers upon request, such as:

• USP/NF• EP

• Kosher• DMF• VMP• GMP• IPEC

Microcel®

Sorb-Cel®(Co-processed e�ervescent base)

Function: E�ervescent agent

Sorb-Cel is a “ready-to-use” co-processed bade for e�ervescent tablets and saches.

(Microcrystalline Cellulose)

Function: compression and compaction agent.

Microcrystalline Cellulose is the preferred excipient for use in tablet, capsule, granule, pellet, sphere, and adsorption of drugs for solid dosage formulations.

By using Sorb-Cel, the weighing and mixing of individual ingredients steps are not required. It speeds up the manufacturing process of e�ervescent formulations and reduces the exposition time of the mix, thus decreasing the risk of up taking humidity.

Sorb-Cel M

Sorb-Cel E

Tablets & Sachets

Sachets

Sorbitol Manitol PEG 4.000 PVP Citric Acid Sodium BicarbonateType Application

101 102 12 200

50

NMT 1%

---

NMT 30%

0.30 – 0.40 0.28 – 0.33 0.30 – 0.40 0.33 – 0.40

100

NMT 8%

---

NLT 45%

160

NLT 10%

NLT 40%

---

180

NLT 10%

NLT 50%

---

Di�erential Analysis

Average Particle Size (microns)

Retained on 60 mesh screen

Retained on 100 mesh screen

Retained on 200 mesh screen

Loss on Drying

Bulk Density (g/cm3)

NMT 7%

Types

NMT = not more than NLT = not less than

Highlights• Good compression • Homogeneous mixtures• Final solution free of insoluble materials and completely clear

(Sodium Starch Glycolate)

Function: super disintegrant aid.

(Croscarmellose Sodium)

Function: Super disintegrant and dissolutiob aid.

(Co-processed MCC + CMC)

Function: suspension and thixotropic agent; thickener and stabilizer agent; chewable agent.

Tabulose SC®

Explosol®

200

580

591

611

681

Types

Components

Viscosity, Cps

Solids Content , %

Principal

MCC %

80,0 – 88,0

86,2 – 91,7

86,2 – 91,7

81,2 – 88,7

86,2 – 91,7

Secondary

CMC %

12.0 – 20.0

8.3 – 13.8

8.3 – 13.8

11.3 – 18.8

8.3 – 13.8

35 – 135

72 – 168

39 – 91

85 – 200

72 – 168

1.2

1.2

1.2

2.6

1.2

A EDP

60 Microns 45 Microns

Di�erential Analysis

Average Particle Size (microns)

Retained on 200 mesh screen

Retained on 325 mesh screen

Loss on Drying

Types

NMT 10%

---

NMT 10%

NMT 2%

NMT 10%

NMT 10%

Solutab®

Solutab is an e�cient super-disintegrant and dissolution aid used in solid dosage formulations due to its high absorption capacity. It also contains no starch or sugar, which makes it attractive for use in nutritional supplement applications.

Explosol is used as a disintegrant aid in pharmaceutical, food and veterinary applications. It functions by quick and high water absorption, resulting in a considerable particle expansion.

Tabulose SC is a co-processed of microcrystalline cellulose and CMC (carboxymethylcellulose sodium). This co-processed is dispersible in water and producing an opaque and high thixotropic gel.

Chewable tablets are a solid pharmaceutical form, where TABULOSE SC 611 is used like a chewable agent, increasing the viscosity inside the mouth, improving the sensorial characteristics of the product.

R&D LaboratoryBlanver´s R&D is sta�ed with experience professionals in developing formulations for solid dosage forms such as uncoated and coated tablets, chewable tablets, and capsules. The development of a formulation starts in small scale and is scaled-up in a pilot plant duplicating the manufacturing stages in a commercial lot. The laboratory is fully equipped with tablet press, conventional coating system, granulators, �uidized bed, intensive mixer, V-blender, planetary blender, andaccela-cota type coater.

Drying and GranulationBlanver´s dryers and granulators are modern and highly e�ective. The high shear area is equipped with an intensive mixer, a granulator, and a �uidized bed. The low shear area is equipped with a planetary blender and a tray oven.

EncapsulationBlanver provides automated equipment that maintains the quality of encapsulated products. These devices have the ability to encapsulate granules or pellets.

E�ervescentBlanver´s e�ervescent area has strict control of humidity and temperature for the production of tablets and sachets.

CompressionBlanver´s compression area is equipped with modern tablet presses that permit the tableting of consistent tablets with less tablet weight variation and a wide range of tablet sizes.

Contract Manufacturing Unit Using the same standard of quality, Blanver has a pharmaceutical plant, located in Taboão da Serra – SP

exclusively for the manufacture of solid dosage forms. This unit is fully equipped with pharmaceutical machinery

and highly skilled professionals who are specialized in the manufacturing and packaging of pharmaceutical

products. Blanver manufacturing facility is Anvisa Licensed according to the current pharmaceutical Good

Manufacturing Practices. Blanver’s commitment with its customers is fully compliance with their needs and

pharmaceutical requirements.

Our services

Special area for Controlled ProductsBlanver is licensed to store and handle controlled drugs such as antiretroviral, immunosuppressant, and antidepres-sant drugs.

MicronizationBlanver has a jet mill micronizer specially developed by their technicians equipped with an independent compressed air system. The particles are moved in circles and the compressed air passesthrough them, increasing its movement which comminutes the particles to a minute size. The micronization operation is controlled by testing the particle size distribution by a laser di�raction analyzer, in order to guarantee consistency of the particle size pro�le.

CoatingBlanver´s technical team has expertise in coating technology and its coating area possesses a conventional pan and very sophisticated Accela-cota type coaters. The team is specialized in various coating techniques that give to the coated tablets a superior �nishing quality.

Primary & Secondary Packaging Blanver is equipped to package the manufactured products in primary and secondary packages. Tablets can be packed in blisters, paper, tubes and bottles. Powders and granules can be packed in sachets. Secondary packages are available in di�erent sizes, in order to accommodate the primary packages enhancing the product stability and facilitating its storage and transportation.

Quality LaboratoriesBlanver´s quality laboratories are fully equipped for physical, chemical, and microbiological tests. These laboratories perform in-process and �nished product tests, guaranteeing full control on manufacturing processes of reduced size and commercial lots.

Provide products and services to the pharmaceutical market with quality, competitiveness and full satisfaction tocustomers and partners.

Blanver Farmoquímica Ltdawww.blanver.com.br

Manufacture Plant – BrazilRua Dr. José Alexandre Crosgnac, 715Itapevi - SP06680-035+55 (11) 4144-9400

Headquarters – BrazilRua Joaquim Faustino de Camargo, 201Taboão da Serra - SP06767-385+55 (11) 4138-8200

O�ce in USA 1515 South Federal Highway, Suite 204Boca Raton - Flórida33432-7404 - USA+1 (561) 416-5513+1 (561) 416-5663

O�ce in EuropeValldaura, 2808195 - Sant Cugat del VallesBarcelona - Spain+34 666 212 824+34 653 858 207