Regulatory/GMP Compliance, Emerging Markets

Hetero Labs recalls losartan potassium tablets due to presence of N-Nitroso-N-methyl-4-aminobutyric acid.

FDA cites Zhejiang Huahai Pharmaceutical in valsartan impurity investigation.

Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.

While food, shelter, and clothing are the primal essentials for life, hope-as embodied by modern medicine-has now become part of that human expectation.

The company’s new UV-1900 UV-VIS spectrophotometer incorporates features that improve usability, regulatory compliance, and performance.

CPhI released the findings of the 2017 India Pharma Market Report, which identified a two-tier manufacturing market and forecasted increased acquisitions by Indian companies, along with a significant improvement in the international reputation of Indian-made pharmaceuticals.

The China Food and Drug Administration has submitted its membership to the International Council for Harmonization.

The three regulatory agencies have agreed to data requirements for development of new antibiotics.

The agency met with the representatives of the East African Community to discuss the creation of a networking agency.

The European Medicines Agency met with European and African regulators to discuss how to improve the availability of safe and effective drugs beyond Europe.

Siegfried Schmitt, PhD, Principal Consultant at PAREXEL, discusses how to mitigate risk in a global regulatory environment.

Domestic sales will be the key driver of revenue growth.

FDA issued a warning letter to Lima & Pergher Industria e Comercio S/A for CGMP violations.

Investment in talent and infrastructure, more quality-by-design skills, and increased communication with global regulators will be needed to combat compliance issues at API and drug manufacturing facilities in India.

Aging populations and increased access to healthcare translates into opportunities for biopharmaceutical companies.

Changes in China’s Food and Drug Administration (cFDA) drug development and commercialization policies make it easier for multinationals and CMOs to manufacture in China for in-country use, reports CMO and consultant PaizaBio.

Cambridge Consultants engaged in a workshop-style dialogue with a cross section of senior personnel from both Indian and multinational pharma companies to debate whether emerging markets are an opportunity to drive sustainable growth. Conclusions from the workshop are presented in this article.

The excipient supplier's cGMP practices have been certified as meeting EXCiPACT standards

Exports and domestic market have each been valued at more than US$15 billion.

A recent Ernst & Young survey highlights the challenges facing Indian pharma

With the Indian pharmaceutical industry on the rise, manufacturing businesses are working together with European and American partners to harness their longstanding experience and reputation in cleanroom manufacturing for a broader pharmaceutical manufacturing marketplace.

Hope abounds for local drug discovery companies despite challenges at home.

Changes in the country’s political landscape may affect the pharmaceutical industry market in the future.

Generic drug manufacturing is no longer the only driver for growth in India's pharmaceutical market as more companies start investing in R&D.

Enhanced R&D efforts and the growing manufacture of finished-dosage drugs in India will shape the country's future success, according to a new report from CPhI.

Ranbaxy and Epirus announce the launch of India's first biosimilar for Remicade.

Indian manufacturers are moving towards high-value, low-volume work, with complex chemistry and intellectual property challenges.

The Brazilian economy is being impacted by internal and external factors, and forecast figures are being quickly revised downwards.

Brazil's pharmaceutical industry is optimistic, but is the pharmaceutical market growing steadily or showing signs of instability?