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USFDA Approvals

Astral Pharma receives USFDA approval for Vadodara plant


Astral Pharma which manufactures sterile antibiotic powder injectables at Makrarpura in Vadodara in Gujarat has received USFDA approval, which facilitates the company to market its product in USA. The company has already received approvals from HPFBI-Canada, TGA-Australia, MCC-South Africa and ANVISA-Brazil. It has entered into strategic business tie up with Sagent Pharmaceutical Inc with whom more than 15 Abbreviated New Drug Application (ANDAs) have been filled for US market.  At Makarpura, the company has two manufacturing facilities- one for Semi Synthetic Penicillin group and other for cephlasporin group.

Suven Life Sciences to invest in research & development

Suven Life Sciences Ltd to invest around Rs.2400 million in research & development. The funds required will be met through issue of equity shares, GDR and ADR and foreign currency convertible bonds. It may be noted, it recently has got USFDA approval for its Suryapet facility at Nalagonda district in Andhra Pradesh. Its Pashamylaram unit has already received that approval in late 2007.

Matrix Laboratories receives USFDA approvals for AIDS Relief vaccine

Matrix Laboratories, a subsidiary of Myland India has received approval from USFDA for AIDS relief vaccine - Emtricitabine and Tenofovir Disoproxil Fumarate tablets, 200 mg /300 mg. These are generic medicine versions of Gilead Sciences Inc’s Truvada tablets which are used to control aids with other medications. Around 30% of AIDS patients in developing countries depend on Matrix anti retroviral products.

Aurobindo, Unichem Laboratories and Ranbaxy has received USFDA approvals for epilepsy drug

Ranbaxy, Unichem Laboratories has received approvals from USFDA for Topiramate tablets which is used for treating epilepsy for adults and kids. The approval provides permission to carry out marketing and manufacturing of the same with strengths of 25mg, 50mg and 100mg. It seems Aurobindo Pharma has got tentative approval for the same.

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