2003

New launches in the Cardiac Segment

December 30, 2003

During 2003 FDC entered the cardiotherapeutic segment, with a range of products introduced in the market at one third the cost of similar brands.

The brands introduced are Amodep, Amodep-AT, Ziblok, Zivast, Zilos, Zinebi and others.

Setting up of Manufacturing Unit

December 19, 2003

The Board of Directors of the Company at its meeting held on 19/12/2003 has approved the proposal of setting up a Manufacturing Unit in the State of Himachal Pradesh, for manufacturing of solid dosages and sterile Ophthalmics / injectables, to meet the Domestic and International demand.

South African MCC Approval

September 08, 2003

The Company's Plant at Waluj, Aurangabad has received GMP accreditation from the Medicines Control Council (MCC) of the Republic of South Africa, for registration of Oral powders and Sterile Ophthalmic dosages.

COS from EDQM for Miconazole Nitrate

September 05, 2003

The Company has obtained a Certificate of Suitability (COS) bearing No. RO-CEP 1998-146 Revision O, from the European Directorate for the Quality of Medicines (EDQM) for Miconazole Nitrate.

US - DMF's assigned for Metaxalone & Fluconazole

September 04, 2003

The Company had submitted type-II DMFs (Drug Master Files) for the bulk drugs Metaxalone & Fluconazole. The US FDA has assigned Nos. 16449 and 16632, respectively, to these DMFs.

FDC's Grand Venture into the Pain Segment

August 26, 2003

FDC has made a grand foray in the nonsteroidal anti-inflammatory segment with the launch of its two new products - Cylorof and Valdez .

Cylorof contains rofecoxib, which belongs to the COX-2 selective inhibitor class of drugs while Valdez contains valdecoxib, which is a second-generation COX-2 selective inhibitor - the most advanced molecule in this class.

Nonsteroidal anti-inflammatory drugs (NSAIDs) are the most commonly used class of medications for treating pain and inflammation because of their excellent analgesic and anti-inflammatory effects. However the use of conventional NSAIDs like aspirin, ibuprofen, naproxen and diclofenac is often associated with potentially life threatening gastrointestinal side effects. The adverse, as well as the therapeutic, effects of NSAIDs result from their non-selective inhibition of the cyclooxygenase (COX) enzyme that is represented by two isoforms: COX-1 and COX-2.

Selective inhibition of COX-2 results in superior GI safety along with retention of excellent efficacy seen with NSAIDs. Thus COX-2 selective inhibitors like rofecoxib and valdecoxib with their efficacy equivalent to NSAIDs but with fewer GI side effects live up to the expectation of an ideal therapy in the management of pain and inflammatory disease.

Various clinical trials have established the efficacy and superior GI safety of Cylorof (rofecoxib) in the following indications:

  • Relief of rheumatoid arthritis in adults
  • Relief of osteoarthritis.
  • Management of acute pain in adults.
  • Treatment of menstrual pain.

Valdez (valdecoxib) is the latest introduction in the COX-2 selective inhibitor class. Its highest selectivity for COX-2 enzyme makes Valdez (valdecoxib) a superior option in terms of efficacy and safety compared to conventional NSAIDs and other COX-2 selective inhibitors.

Study results suggest that Valdez (valdecoxib) is significantly less likely to cause ulcers than diclofenac and may be an option for the long-term treatment of the pain and inflammation of rheumatoid arthritis.

Valdez (valdecoxib) has faster onset of action than other agents and provides excellent results in the treatment of signs and symptoms of osteoarthritis, adult rheumatoid arthritis, primary dysmenorrhoea and surgical pain.

With their unique price advantage Cylorof and Valdez are all set to make massive inroads in the pain segment.

Zodlin & 1-Al

August 25, 2003

ZODLIN - The Advanced Antibacterial for Unprecedented Action.

ZODLIN , one of FDC's recent introductions is a brand of Linezolid, which is aimed at treating serious, difficult-to-treat, life-threatening infections. With the introduction of ZODLIN , FDC has further reinforced it's strong presence in the antibiotic/ antibacterial segment and has taken another leap forward in it's mission to reach out to an ever-expanding number of seriously ill patients.

Infectious diseases are one of the largest killers worldwide and remain the leading cause of global deaths even today. Treating these infections has, in recent years, become extremely problematic because of the increasing emergence of multidrug- resistant bacterial strains as a cause of serious infections.

The Gram-positive bacteria, particularly the Staphylococcus species, the Enterococcus species and the Streptococcus species, which are acquiring resistance to most commonly used antibiotics, are emerging as the most dreadful species. Most of these species have also acquired varying levels of resistance to the higher antibacterials currently employed in these serious infections, namely Vancomycin and Teicoplanin.

Linezolid (ZODLIN) is the first agent from a new class of antibacterials, the oxazolidinones. It shows excellent activity against almost all Gram-positive bacteria, including the multi-drug resistant species like methicillin-resistant Staphylococcus aureus (MRSA), glycopeptide-intermediate S.aureus (GISA), vancomycin-resistant enterococci(VRE) and penicillin-resistant Streptococcus pneumoniae. The drug also shows good activity against certain anaerobes.

ZODLIN's unique mechanism of action precludes any chances of resistance development and it's extremely high (approx. 100%) oral bioavailability gives the option of oral therapy even in serious infections, an option which was not available before. ZODLIN also reduces the length of hospital stay for the patient and thereby brings down the treatment costs drastically.

ZODLIN is also a well-tolerated drug (with the few side-effects seen being mild in nature) unlike vancomycin and teicoplanin, which have several possibly serious side-effects including severe hypersensitivity reactions, ototoxicity and nephrotoxicity. Moreover, ZODLIN by virtue of it's unique pharmacokinetic properties, shows minimal incidences of drug-drug interactions and is safe for use even in geriatric patients and in patients with impaired renal or hepatic function.

With the number of patients acquiring serious Gram-positive infections increasing day by day and with the alarming pace at which bacteria are gaining resistance to commonly used antibiotics, ZODLIN is poised to play a vital role in the management of serious infections.

1 - AL - One above ALL in ALL Allergies:
FDC ventures into the highly lucrative 300 crore antiallergic market with the latest third generation blockbuster molecule 'Levocetirizine' with the brand name 1-AL .

Allergy affects 1 in 5 people worldwide and is a significant cause of increased morbidity. The mainstay in the treatment of allergy is the antihistamine class of drugs, which act as potent H1 receptor antagonists. Despite the advent of newer antiallergics cetirizine still enjoys the best patronage among the users of these medications. Over a decade cetirizine has been the best selling most popular antihistamine but is associated with major drawbacks like sedation and psychomotor impairment.

Now the market has witnessed the launch of the latest 3rd generation antihistamine Levocetirizine, which is the purer form of the time tested and trusted top selling antiallergic drug - cetirizine. Levocetirizine is no doubt better than the best, as it possesses all the goodness of cetirizine without the drawback of sedation thus levocetirizine is all set to replace the widely presented cetirizine.

The launch of 1-AL (Levocetirizine) offers the advantage of the safest option available with superior characteristics, like highest selectivity and safety.

1-AL offers:

  • Faster onset of action.
  • Best efficacy in nasal and skin allergies.
  • No sedation and psychomotor function impairment
  • Once daily dosage.
  • Better patient compliance.

In view of the mass potential seen for levocetirizine, 1-AL is expected to further strengthen FDC's presence in the mass market.

FDC Obtains injunction order restraining workmen of Roha Plant from strike

August 11, 2003

The Company had received a notice of a proposed strike by the workmen of Roha Plant to be effective from 11.08.03 or thereafter. However, the Company has obtained an injunction order from the Industrial Court at Thane, restraining the workmen at Roha Plant from going on strike.

The workmen of Roha Plant have not so far proceeded on strike.

Nizi & Osteoshield

January 15, 2003

NIZI:

NIZIFDC has recently introduced a value-added product in the muscle relaxant area of therapeutics. The new product launched, NIZI, combines one of the latest muscle relaxants Tizanidine with Nimesulide, a painkiller popular for its efficacy and safety, in a special formulation using B-cyclodextrin; such a formulation is launched for the first time in India. B-cyclodextrin in NIZI, enhances the bio-availability of otherwise sparingly soluble Nimesulide and thus quickens its onset of action. Thus NIZI is especially designed to provide faster relief from pain and spasm than any other muscle relaxant containing plain Nimesulide. To add to this core benefit, NIZI also relieves pain at rest and pain on movement - a typical outcome of conditions involving muscle spasm. And last but not the least NIZI is very well tolerated with no incidences of GI side effects. This makes NIZI a perfect solution for all kinds of muscle spasm viz., low back pain, stiff neck, shoulder pain, spondylosis & slip disc.

 

OSTEOSHIELD - Fortifies Life after 45:

OSTEOSHIELDAs women approach the age of 45 years, their lives are marked with significant changes with a stage called 'Menopause'. It is a stage where the female body experiences wide-ranging changes, due to the depletion of an important hormone, Estrogen. At present, to take care of these problems Hormone Replacement Therapy (HRT) has been the only complete treatment, but HRT is associated with drawbacks like venous thromboembolism, breast & endometrial cancer. Recently, highly encouraging research findings on Soya Protein have indicated Soya Protein as an alternative to HRT. So, after a thorough study of the intensive research on Soya Protein, FDC has launched Osteoshield - a dietary supplement based on soya protein. Osteoshield is specially designed to help a woman to line through menopausal changes successfully. The soya protein in Osteoshield is rich in isoflavones (plant estrogens) and calcium (in more absorbable form).

Osteoshield will help in:

  • Reducing disturbing menopausal symptoms like night sweats, hot flushes & vaginal dryness
  • Reducing the risk of bone degeneration
  • Building bones
  • Reducing the risk of cardiovascular disease by virtue of its anti-cholesterol and anti-oxidant properties
  • Reducing the risk of memory loss

Regular use of Osteoshield with milk, as recommended, will successfully respond to the nutritional demands and help a woman stay healthy & happy after 45.