Emcure Pharmaceuticals becomes the First Company in India to launch the 750 mg injectable variant of Ferric Carboxymaltose
Pune, May 17th, 2023: Emcure Pharmaceuticals Limited (EPL) has announced the launch of Orofer FCM 750, a new extension of its parenteral iron brand containing Ferric carboxymaltose (FCM).
The new dosage variant is designed to provide a more effective and convenient option for patients with iron deficiency and iron deficiency anaemia (IDA). DCGI-approved FCM is indicated for treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. It is already available in dosage forms 1000mg/ 20ml and 500mg/ 10ml single-use vials. With this latest launch, Orofer FCM will also be available as a 750mg/15ml dosage form recommended for treatment of patients with Hemoglobin less than 10 g/dl & bodyweight between 35 kg to 70kg. Orofer FCM can only be obtained through a prescription from a registered medical practitioner.
IDA is a significant burden for women, especially during later trimesters of pregnancy and secondary to postpartum hemorrhage (PPH). Approximately 36% of maternal deaths are attributed to PPH1 as per Indian studies; whereas anemia during pregnancy is reported among 45.7% and 54.3% of pregnant women in urban and rural areas2, respectively, hampering post-partum maternal and early child health outcomes. Indian studies using FCM for the treatment of IDA in pregnancy have indicated that most patients have mean Haemoglobin <10 g/dl.3,4 They may require FCM 1500 mg at body weight between 35-70 kgs. A single dose of FCM up to 750 mg of iron can be infused in a short time frame of 15 minutes diluted in 250 ml of normal saline5.
Anil Kothiyal, President India Business at Emcure Pharmaceuticals said “At Emcure Pharmaceuticals, we recognize IDA as a major public health concern in India, particularly among women. We feel satisfied to introduce Orofer FCM 750 to help address this significant burden of IDA in India. This bolsters our commitment to providing innovative and effective solutions to meet the healthcare needs of patients in India. We believe Orofer FCM 750, with its convenient dosage strength, will provide an important treatment option for patients with IDA who may not have responded to oral iron preparations or who cannot tolerate them. Orofer FCM will be available in leading pharmacies and hospitals shortly”
In April 2018, the Intensified National Iron Plus Initiative (I-NIPI) operational guidelines for the “Anemia Mukt Bharat” Programme recommended FCM as the first-line treatment for severe and selected cases of mild-to-moderate anemia in pregnant women in India.6 FCM, a unique iron complex consists of a ferric hydroxide core stabilized by a carbohydrate shell, enabling controlled iron delivery to target tissues. FCM can elevate serum ferritin and Hemoglobin levels and provide better compliance as compared to oral iron and iron sucrose therapy.
Emcure Pharmaceuticals Limited aims to address the unmet medical needs of patients suffering from IDA in India by providing a reliable and convenient treatment option.