Granules India Limited

From Wikipedia, the free encyclopedia
Jump to: navigation, search
Granules India Ltd.
Type Public
Traded as BSE532482
NSEGRANULES
Industry Pharmaceuticals
Founded Hyderabad, 1984 [1]
(by Mr. C Krishna Prasad)
Headquarters Hyderabad, India
Key people C. Krishna Prasad (MD)
Harsha Chigurupati (ED)
VVS Murthy (CFO)
Products Finished Dosages (FDs)
Pharmaceutical Formulation Intermediates (PFIs)
Active Pharmaceutical Ingredients (APIs)
(Paracetamol, Ibuprofen, Methocarbamol, Metformin, Guafenesin, etc.)
(See complete products listing)
Employees 655
Website www.granulesindia.com

Granules India Limited is an Indian pharmaceutical company based in Hyderabad, India. The Company manufactures Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs) which are distributed in over 50 countries.[2] Granules manufactures several off-patent drugs, including Paracetamol, Ibuprofen, Metformin and Guaifenesin, on a large scale for customers in the regulated and semi-regulated markets. [3][4]

History[edit]

Granules’ predecessor company, a partnership called Umbrella Laboratories, was established in 1984.[1] Triton produced Paracetamol API at its Bonthapally factory on the outskirts of Hyderabad. Triton scientists found a more efficient way to produce the Paracetamol API, which led to lower capital and raw material requirements. In 1987, Triton became the only Indian company aside from Dr. Reddy’s Laboratories to export pharmaceutical products to the U.S.[5]

Though Triton was growing as an API manufacturer, management decided it could create a value added version of its product. In order to distinguish itself from competitors, Triton management pioneered the concept of manufacturing and selling in bulk granulated Paracetamol, also known as direct compressible grade material (DC), or “PFI” - a term coined at Granules. In 1991,[1] management set up a new entity, which was incorporated as Granules India Limited. Soon after Granules applied the PFI concept to other APIs and began exporting the material to various markets including the U.S., Germany and Australia.[6]

In 1995,[1] Granules became a public company, after having initial public offerings (IPOs) on the Bombay Stock Exchange and Hyderabad Stock Exchange. [7]

In 2002,[1] Granules commenced construction on a new PFI plant in Gagillapur. The facility opened in August 2003 with a capacity of 7,200 MTPA. The facility is one of the largest of its kind in the world and has a 6 MT PFI batch size, which is one of the world’s largest. In order to secure API for its Ibuprofen PFI, Granules formed a joint-venture with Hubei Biocause Heilen Pharmaceutical to create Granules Biocause in Wuhan, China.[8] The jointly owned Ibuprofen plant has a capacity of 4,800 MTPA and is among the biggest plants of its kind in the world. [9]

Due to the export nature of its business, Granules continued to expand its reach by receiving additional regulatory approvals for major markets. In 2001, the API and PFI blocks at Jeedimetla facility received approval from the U.S. FDA. Shortly after the approval, the Company decided to manufacture Guaifenesin, Metformin and Ibuprofen PFIs. In 2004, Granules obtained approval from U.S. FDA, Australian TGA and German Health Authority for the Gagillapur facility. In 2007, the Bonthapally new API facility, manufacturing 12,000 MT of Acetaminophen / Paracetamol API was audited and approved by the FDA following a special request made by Granules to schedule the inspection of this plant.[10]

In 2008, Granules commenced operations at its finished dosage block at Gagillapur. The new block has enabled Granules to provide products throughout the pharmaceutical value chain to customers. The state-of-the-art facility has an annual capacity of 6 billion tablets per year and is scalable up to 12 billion tablets per year.[11]

The third piece of the business is the API division. Granules manufactures APIs for several drugs including Paracetamol, Ibuprofen, Metformin and Guaifenesin through 3 facilities.

Infrastructure[edit]

Granules has four plants; three plants are located in India while the fourth plant is through a joint-venture with Hubei Biocase in Wuhan, China. The Company’s plants have met the requirements of international authorities including the U.S. FDA, WHO, Australia TGA and others.

Gagillapur[edit]

Gagillapur Plant

The Gagillapur facility was re-audited by the FDA and approved, following the filing of an ANDA by one of Granules’ customers in the United States.[10] It has a Finished Dosage block, a PFI block and a Research & Development Facility.

The finished dosage block started in October, 2008 and follows cGMP standards. The plant has the capacity of 6 billion Tablets/Caplets and is scalable to 12 billion tablets.[11] The plant can produce several finished dosage forms including caplets, capsules, press-fits and effervescent tablets. The coating capacity is 2 billion and scalable to 4 billion. The plant is currently able to provide packing in bulk, bottle and blister packages. Currently, the finished dosage plant has regulatory approvals from EU (Portuguese Health Authority), WHO GMP and Australian TGA[12] The U.S. FDA also approved the Company’s Abbreviated New Drug Application (ANDA) for Metformin 500 mg, 850 mg and 1000 mg.[13]

The PFI block was commissioned in mid-2003 which operates on a modular concept split between two modules; fluid bed granulation and high shear granulation. The factory has one of the world’s largest PFI batch size of 6 MT. The block produces single and multiple-active PFIs and has a capacity of 7,200 MTPA.[11] It has regulatory approvals from EU, GHCA, and TGA Regulatory Authorities [12]

The R&D/Pilot facility provides Finished Dosage and PFI Development. The R&D team consists of 60 members with independent Formulations R&D, Analytical R&D, RA and sourcing activities with Class 100,000, spread over 5,200 sq. ft. It has the ability to manufacture clinical/exhibit batches, develop pilot products and assist in filing ANDAs/Dossiers in the U.S., Canada, Europe, Australia and other countries. It has High shear as well as fluid bed granulation Geometrical Scaled down as per the 10x standard. The Pilot Facility is approved by Canadian TPD and Australian TGA for small volume production.[14]

Jeedimetla[edit]

Jeedimetla Plant

The API facility has a capacity of 1,800 MTPA. Also, there is a Product Development Lab, R&D and Pilot Facility(Product Development). The facility is approved by the U.S. FDA, KFDA, TGA, and EDQM Regulatory Authorities

The PFI facility has a capacity of 1,200 MTPA with a 1.2 MT Batch Size. It can blend multiple API in a single PFI and is approved by the U.S. FDA, and German Health Association (GHA) Regulatory Authorities.[12]

Bonthapally[edit]

Bonthapally Plant

This facility is a Paracetamol API production unit. The unit produces 6 grades of Paracetamol API and has a batch size of 4.8 MT. The facility has a capacity of 10,000 MTPA and has received approval from the U.S.FDA, WHO GMP, EU, and COS Regulatory Authorities

Wuhan[edit]

Wuhan Plant

This facility is an Ibuprofen API production unit. The facility is run through a 50:50 joint-venture with Hubei Biocause. The facility has a capacity of 4,800 MTPA and has received approval from the U.S. FDA, EDQM, TGA, Russian Authority, and MCC Regulatory Authorities.[15]

See also[edit]

References[edit]