Manufacturing

Articles

Piramal Pharma Solutions plans to construct a multipurpose ADC manufacturing and aseptic fill/finish facility in Grangemouth, Scotland, and to upgrades its existing API manufacturing facility in Morpeth, England.

Piramal Pharma Solutions Expands and Upgrades UK Manufacturing Facilities

Jennifer Markarian is manufacturing reporter for Pharmaceutical Technology.

Experts share best practices in designing, manufacturing, and scaling up dry powder inhaler and metered dose inhaler drug–device combination products for inhalation drug delivery. 

Considerations for DPIs and MDIs in Inhalation Drug Delivery

Hallie Forcinio is packing editor for Pharmaceutical Technology and Pharmaceutical Technology Europe, editorhal@sbcglobal.net.

Trends affecting primary pharmaceutical packaging include the shift to more complex drug-device combination products.

Primary Packaging for Combination Products

The contraceptive is expected to receive new chemical entity designation from FDA, giving it patent protection beyond 2030. It will be launched in early 2021, pending FDA approval. 

Mayne Enters 20-Year Agreement with Mithra for Oral Contraceptive Commercialization

The company has expanded its high-potency API capability at its Riverview, MI, facility to serve the growing antibody drug conjugates market.

Piramal Pharma Solutions Invests $10 million to Expand HPAPI Capability

A simple, one-part DPI aims to make inhalation drug treatment more accessible and affordable.

Hovione Technology Develops Blister-Based Inhaler

Mark Gordon is product manager at Trelleborg Sealing Solutions Healthcare and Medical

Andrew Gaillard is global director at Trelleborg Sealing Solutions Healthcare and Medical. 

API can be mixed with silicone and other polymers to create drug-delivery combination products. 

Designing Combination Products

Aptar now manufactures its child-resistant pump, designed to meet US CPC requirements, at its facility in Congers, New York. 

Aptar Adds Nasal Pump Manufacturing Capacity

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Recent legislation and PDUFA initiatives aim to streamline oversight and testing requirements.

Combination Products Raise New Manufacturing Challenges

Shana K. Cyr is an attorney at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.

Paula Miller is an attorney at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.

Deborah M. Herzfeld is an attorney at McNeill Baur PLLC.

Robert F. Shaffer is an attorney at Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.

The authors discuss regulatory and patent issues with combination products.

Manufacturing, Combination Drugs