The Bharuch-based J B Chemicals and Pharmaceuticals Ltd (JBCPL) has commenced commercial production of tablets at its facility in Daman this month. |
Commercial production of Doktor Mom lozenges at this 100 per cent export oriented unit (EOU) in Daman had already commenced effective September 1, 2003. |
The facility is expected to strengthen the company's competitive edge and translate into attractive tax breaks, said JBCPL executive director (production) Kamlesh Udani. |
The profits derived from the 100 per cent EOU facility will be totally tax free in the hands of the company until the assessment year 2009-10. |
The profits derived from the tablets plant will be tax-free for the first five years and 30 per cent of the profits will be tax-free for the next five years. |
The official said the lozenges section of the Daman plant will have a capacity of 200 kgs per hour, which translates to about 200 crore lozenges per annum. |
The tablets division, Udani said, will have a capacity of ten crore tablets a month. |
Earlier this month, the company had received approvals from the US Food and Drug Administration (USFDA) for its pharmaceutical (tablets) and active pharmaceutical ingredients (APIs) manufacturing facilities at Panoli, Gujarat. |
Based on the inspection conducted in October 2003, USFDA had classified these facilities as acceptable for the US market. |
The approval will enable the company to explore the large opportunity in the regulated markets in the European and Latin American countries, in addition to the US market. |
This will also pave way for the company's future abbreviated new drug applications (ANDAs) and drug master files (DMFs) submissions. |
The Company already has the US FDA approval for its metronidazole facility at the Thane-Belapur area in Maharashtra. |
JBCPL plans to set up strategic business units (SBUs) to enter into the high-growth therapeutic segments like neuro psychiatry and oncology with a range of innovative products. |
The facility at Panoli is equipped to manufacture various tablets dosage forms to cater to the growing global generics market, Udani said. |
"The facility approval endorses JBCPL's sustained commitment to compliance to current good manufacturing practices (cGMP)," the ED said. |