Bihoku Funka Kogyo Co., Ltd.

Calcium carbonate for pharmaceutical grade

General Information

  • Appearance: White fine powder
  • Regulation: In Japan, pharmaceutical-grade calcium carbonate must be manufactured in a certified pharmaceutical raw material plant.
  • Applications: Antacid medicine, Tablet excipient
  • Source: Pharmaceutical grade-calcium carbonate must be produced from highly pure limestone in a fully-equipped, clean room that has also had extremely fine dust and dirt removed.

Product Features

  • We have mines with abundant reserves of high-purity limestone.
  • We own Karabitsu mine, which produces the best quality crystalline limestone in the world.
  • Karabitsu mine has 100 million tons in reserve, enough to last for 500 years.
  • We are only manufacturer of Calcium carbonate for pharmaceuticals in Japan.
  • We are Halal, FSSC22000, ISO9001, ISO14001 and GMP (Good Manufacturing Practice) certified.
  • We carry out quality control and production in accordance with cGMP.
Calcium carbonate for pharmaceutical grade

Appearance

Packing

Paper bag of 20 kgs. net

Basic Information

CAS No.
471-34-1
Chemical formula
CaCO3
FW/MW
100.09
Specific gravity
2.7
Melting point
1340 degree C.
Solubility
0.0014% (25 degree C.)
Appearance
White fine powder
Harmonized system (HS code)
2836.50
Country of origin
Japan
UN number
N/A

Specification

Precipitated Calcium carbonate JP

Item Japanese Pharmacopoeia Standards Precipitated Calcium carbonate JP
Acid-insoluble substance 10.0 mg max. 10.0 mg max.
Alkali metals and magnesium 5.0 mg max. 5.0 mg max.
Heavy metals 20 ppm max. 20 ppm max.
Barium No green color appears No green color appears
Arsenic(as As) 5 ppm max. 5 ppm max.
Loss on drying 1.0% max. 1.0% max.
Purity 98.5% max. 98.5% max.
Packaging - 20/25 kgs.
Whiteness - 96.0%
Average particle size (by Air-permeability method) - 2.5 μm
D50 Particle size (Reference) (Laser diffraction analysis (McrotracMT3300) - 8.0 μm

Precipitated Calcium carbonate JP Grade A

Item Japanese Pharmacopoeia Standards Precipitated Calcium carbonate JP Grade A
Acid-insoluble substance 10.0 mg max. 10.0 mg max.
Alkali metals and magnesium 5.0 mg max. 5.0 mg max.
Heavy metals 20 ppm max. 20 ppm max.
Barium No green color appears No green color appears
Arsenic(as As) 5 ppm max. 5 ppm max.
Loss on drying 1.0% max. 1.0% max.
Purity 98.5% max. 98.5% max.
Packaging - 15 kgs.
Whiteness - 96.0%
Average particle size (by Air-permeability method) - 1.0 μm
D50 Particle size (Reference) (Laser diffraction analysis (McrotracMT3300) - 2.0 μm

Precipitated Calcium carbonate JP Grade B

Item Japanese Pharmacopoeia Standards Precipitated Calcium carbonate JP Grade B
Acid-insoluble substance 10.0 mg max. 10.0 mg max.
Alkali metals and magnesium 5.0 mg max. 5.0 mg max.
Heavy metals 20 ppm max. 20 ppm max.
Barium No green color appears No green color appears
Arsenic(as As) 5 ppm max. 5 ppm max.
Loss on drying 1.0% max. 1.0% max.
Purity 98.5% max. 98.5% max.
Packaging - 25 kgs.
Whiteness - 95.0%
Average particle size (by Air-permeability method) - 5.5 μm
D50 Particle size (Reference) (Laser diffraction analysis (McrotracMT3300) - 20 μm

Precipitated Calcium carbonate JP Grade C

Item Japanese Pharmacopoeia Standards Precipitated Calcium carbonate JP Grade C
Acid-insoluble substance 10.0 mg max. 10.0 mg max.
Alkali metals and magnesium 5.0 mg max. 5.0 mg max.
Heavy metals 20 ppm max. 20 ppm max.
Barium No green color appears No green color appears
Arsenic(as As) 5 ppm max. 5 ppm max.
Loss on drying 1.0% max. 1.0% max.
Purity 98.5% max. 98.5% max.
Packaging - 15 kgs.
Whiteness - 92.5%
Average particle size (by Air-permeability method) - 11 μm
D50 Particle size (Reference) (Laser diffraction analysis (McrotracMT3300) - 30 μm

Regulatory Approvals

ISO 9001
Certified
ISO 14001
Certified
REACH
N/A
Halal
Certified
Kosher
N/A
FDA
N/A
FSSC 22000
Certified
GMP
Certified

Main Applications

  • Antacid medicine
  • Tablet excipient

FAQ

Do you ship overseas?
Yes, we have been shipping overseas for a significant period of time. In recent years, we have increased the shipment of pharmaceutical-grade Calcium carbonate for use as antacids and excipients to South East Asia.
How much pharmaceutical-grade Calcium carbonate do you supply each year?
Including domestic and export shipments, we supply about 200 M/T a year.

End User Comments

Overseas pharmaceutical manufacturer

“Bihoku's Calcium carbonate is manufactured based on GMP quality control standards, so we can use it with confidence.”

Who manufactures Calcium carbonate for pharmaceutical grade?

Bihoku Funka Kogyo Co., Ltd.

Aerial Shoot

Introduction

  • We are the leading suppliers of Calcium carbonate in the fields of food additives and pharmaceuticals.
  • We own Karabitsu mine, which produces the best quality crystalline limestone in the world. With 100 million tons in reserve, there is enough limestone to last for 500 years.
  • We are the only manufacturer of pharmaceutical-grade Calcium carbonate in Japan.

History

1942 Established in Okayama prefecture, Japan.
Niimi Plant (No.1) completed.
Yogai mine developed.
1965 Niimi Plant (No.2) completed.
1995 Karabitsu mine developed.
2002 Head office, Niimi Plant, Karabitsu mine and Osaka office ISO 9001:2000 certified.
2003 Fukushima Plant and Otakine mine ISO 9001:2000 certified.
2004 Head office, Niimi Plant, Tetta Plant, Osaka office and Karabitsu mine ISO 14001:2004 certified.
2005 Tetta Plant ISO 9001:2000 certified.
2016 Fukushima Plant and Otakine mine ISO 14001:2004 certified.
Tetta Plant halal certified.

Company Overview (as of March 1, 2021)

Company name Bihoku Funka Kogyo Co., Ltd.
Head office 704, Nishigata, Niimi City, Okayama, 718-0017, Japan
Date of establishment January 1, 1942
Capital JPY 35 million
Number of employees 156
Location Head office: Okayama
Branch office: Osaka
Plants: Fukushima, Okayama

Plants

Plant location map

Niimi Plant

  • The Niimi plant, which is our primary plant and is located near Karabitsu mine in Okayama prefecture, started operations when our company was established.

    ISO 9001
    ISO 14001

    Calcium carbonate (Industrial grade)

Fukushima Plant

  • The Fukushima plant is located in Tamura city, Fukushima prefecture. It mainly manufactures industrial grade Calcium carbonate for eastern Japan.

    ISO 9001
    ISO 14001

    Calcium carbonate (Industrial grade)

Tetta Plant

  • The Tetta plant is adjacent to the Karabitsu mine. The Niimi plant manufactures Calcium carbonate for food additives and pharmaceuticals in a completely clean room that eliminates extremely fine dust and dirt.

    ISO 9001
    ISO 14001
    Halal
    Pharmaceutical manufacturing license
    GMP (Good Manufacturing Practice)
    FSSC 22000

    Calcium carbonate (Pharmaceutical grade and food grade)

Karabitsu mine

  • The Karabitsu mine produces some of Japan's finest crystalline limestone and has an estimated reserve of 100 million tons. High-purity, high-whiteness products are backed by this excellent raw material.

    ISO 9001
    ISO 14001

    Calcium carbonate (Industrial grade)

Otakine Mine

  • The Otakine mine produces high-grade, high-white limestone with high crystallinity and few impurities.

    ISO 9001
    ISO 14001

    Calcium carbonate (Industrial grade)