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The only technical publication dedicated to readers who formulate, manufacture, or package solid dosage forms.

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Posted April 19, 2019

ROCKVILLE, MD—The Office of Generic Drugs (OGD) published its Annual Report for 2018, the first year the Generic Drug User Fee Amendments Reauthorization (GDUFA II) was in effect. During the year, the agency successfully implemented many of the provisions in GDUFA II and the FDA Reauthorization Act of 2017 (FDARA). These provisions included requests for pre-ANDA meetings, reconsideration requests, one-time marketing status updates to the “Orange Book,” and competitive generic therapy designation and exclusivity requests. The FDA also approved or tentatively approved 1,021 Abbreviated New Drug Applications (ANDAs) and published more than 250 new or revised guidances, product-specific guidances (PSGs), and manuals of policies and procedures (MAPP) for stakeholders. The full report can be accessed at www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/GenericDrugs/ucm631710.htm.

Posted April 19, 2019

ANN ARBOR, MI—NSF International, an independent public health and safety organization, now offers interim gap or pre-assessment audits for the Global Retailer and Manufacturer Alliance (GRMA) standards. Earlier this year, the GRMA announced the publication of NSF/ANSI 455, a set of consensus-based GMP auditing standards for manufacturers of dietary supplements, cosmetics, personal-care products, and over-the-counter drugs, to reduce the number of audits and the associated costs of auditing to multiple independent standards. GRMA trained NSF’s auditors to conduct interim gap audits, and the auditors will eventually provide certification to the GRMA manufacturing quality system standards.

Posted April 19, 2019

ARLINGTON, VA—IPEC-Americas volunteers recently added a frequently asked questions (FAQs) annex to the 2018 Excipient Master File Guide, which was reissued in 2019. The annex answers the 15 most common questions asked by excipient manufacturers regarding excipient Drug Master Files (DMF) (Type IV). The guide can be downloaded for free at ipecamericas.org/reference-center/document-depot.

Posted April 19, 2019

SILVER SPRING, MD—The FDA finalized two guidances that focus on HIV prevention and treatment. “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis” addresses the agency’s current thinking on the overall development program and clinical trial designs to support the development of pre-exposure prophylaxis (PrEP) medications, which are long-acting systemic drug products used to prevent sexually acquired HIV-1. This guidance includes nonclinical and clinical recommendations specific to the development of systemic drug products like PrEP. The final guidance “Pediatric Human Immunodeficiency Virus Infection: Drug Product Development for Treatment,” provides general recommendations on the development of antiretroviral drug products to treat pediatric patients with HIV infections. The guidance specifically addresses when to initiate pediatric formulation development and begin pediatric studies and offers approaches for enrollment of subjects into pediatric studies to help facilitate drug product development.
The agency also published two revised draft guidances on bioavailability and food effects on medicines, including recommendations on new drug development. “Bioavailability Studies Submitted in NDAs or INDs —General Considerations,” provides recommendations to sponsors submitting bioavailability information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. The draft guidance “Assessing the Effects of Food on Drugs in INDs and NDAs — Clinical Pharmacology Considerations,” provides recommendations to sponsors planning to conduct food-effect studies for orally administered drug products as part of INDs, NDAs, and supplements to these applications.

Posted April 19, 2019

FILDERSTADY, Germany—Herma, a provider of labeling and self-adhesive products, moved its labeling machinery division to a new facility at its German headquarters, consolidating its self-adhesive materials, labels, and labeling machines into a single location. The company will further expand its headquarters by adding a self-adhesive coating plant adjacent to the labeling machine facility and anticipates completing the site in autumn 2019.

Posted April 19, 2019

BRUSSLES, Belgium—ExciPact, an international non-profit organization that provides voluntary third-party GMP certification to excipient manufacturers, certified Valtris Specialty Chemical’s manufacturing site in Cleveland, OH. The certification demonstrates that the site manufactures metal stearates according to ExciPact’s

Posted April 19, 2019

NORTHUMBERLAND, UK—Sterling Pharma Solutions, a CDMO specializing in small molecule API development and manufacture, acquired CiVentiChem’s US facility in Cary, NC. The facility, located in the Research Triangle Park, will allow Sterling to offer a local presence to its US clients and enhance its chemistry development capabilities to support pre-clinical and early-phase clinical supply.

Posted April 19, 2019

LUXEMBOURG, Belgium—Azelis, a leading distributor of specialty chemicals and food ingredients, acquired rival Chemroy, Brampton, ON. The acquisition strengthens Azelis’s position in the coating, adhesives, construction, ink, food, pharmaceutical, nutraceutical, and personal care industries.

Posted April 19, 2019

TREDEGAR, Wales—PCI Pharma Services, a full-service CDMO, will expand its flagship manufacturing center in Tredegar, Wales, doubling its high potency tableting capacity and increasing throughput to support recent and anticipated product launches. The dedicated contained-manufacturing facility has processed more than 60 highly potent products since opening in 2013.

Posted April 19, 2019

SOMERSET, NJ—Catalent Pharma Solutions will invest $27 million to commercialize Zydis Ultra, an oral disintegrating tablet (ODT) coating that allows for an increased drug load and taste-masking when used with the company’s Zydis ODT dosage form. The coating enables the active ingredient dosage to be up to four times higher than in a conventional Zydis ODT while maintaining the speed of dispersion and superior mouth feel. More than 36 products have been launched using the Zydis platform in more than 60 countries. The coating expands the range of drug candidates that can be formulated using the company’s ODT platform, including analgesics, anti-allergy treatments. and anti-infectives.