Displaying 1–25 of 746 results for cGMPs

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Today's solid dose drugs: High potency, high stakes

(Article)

Exploring best-practice manufacturing strategies for highly potent oral solid dosage forms

Sun Pharma hit with Form 483 for Halol facility

(News)

Sun Pharmaceutical said it has received four observations from the U.S. FDA for its Halol facility in Gujarat.

Still got it: Tips and tricks to keep your older pharma plants riding high

(Article)

In pharma plants, age definitely matters.

India's Cadila Healthcare gets 14 FDA observations

(News)

Cadila Healthcare disclosed that the U.S. FDA has issued 14 observations after inspecting its manufacturing facility at Moraiya in Ahmedabad (western India).

FDA warns Jubilant India plant

(News)

The U.S. FDA has issued a warning letter to Jubilant Generics for its Roorkee, North India facility.

FDA hands Akorn its fourth 483

(News)

The FDA has issued Akorn a Form 483, following an inspection of the drugmaker's manufacturing plant in New York, just weeks after Akorn received a warning letter for its Illinois site.

FDA issues six observations for Lupin plant

(News)

The U.S. FDA has issued six observations after the inspection of Lupin's Pithampur facility in Madhya Pradesh (central India).

Regulatory Rewind

(Article)

A mix of the biggest hits from 2018

Tris Pharma recalls infant ibuprofen

(News)

Tris Pharma has voluntarily recalled three lots of Infants' Ibuprofen Concentrated Oral Suspension because the products have been found to potentially have higher concentrations of ibuprofen.

China vax scandal intensifies

(News)

After a second scandal over substandard vaccines from Changchun Changsheng Biotechnology, the Chinese public is voicing its outrage.

EMA recalls drugs made with Chinese API due to cancer fears

(News)

The European Medicines Agency is recalling a number of high blood pressure and heart drugs containing an ingredient made in China after an impurity that may cause cancer was found in them.

FDA adds EpiPens to drug shortage list

(News)

The U.S. FDA added EpiPen 0.3 mg and EpiPen Jr 0.15 mg Auto-Injectors as well as the authorized generic versions to its drug shortages list, citing issues relating to good manufacturing practices.

FDA looks to shut down unapproved stem cell clinics

(News)

The U.S. FDA is seeking permanent injunctions to stop two stem cell clinics from marketing stem cell products without FDA approval, citing significant deviations from current good manufacturing practice requirements.

Atrium Innovations Modernizes Quality Management

(Article)

Atrium improves audits and complaints, change control, and product release processes with immediate access to information and operational visibility

Tris Pharma, a Pfizer CMO, warned by FDA

(News)

The U.S. FDA sent a Warning Letter to Tris Pharma, a CMO that manufacturers ADHD drug, Quillivant, for Pfizer, citing significant violations of CGMP regulations.

Aurobindo injectables facility hit with 483 due to cleanliness

(News)

The U.S. FDA has issued nine observations after inspection of Aurobindo Pharma’s unit 4 formulation facility in Hyderabad.

India regulator reorgs, changes leader

(News)

India’s Central Drugs Standard Control Organization (CDSCO) announced (via Twitter) that the Drug Controller General of India has been received of his post and Dr. S. Eswara Reddy will take over as DCGI.

Sun Pharma recalls over 17.5K bottles of nasal spray in U.S.

(News)

Sun Pharmaceutical Industries, the U.S. arm of India’s Sun Pharma, is recalling over 17.5 thousand bottles of antihistamine Azelastine HCl nasal solution from the American market.

Cell Therapies Come of Age: Overcoming Challenges Within the Regulatory ...

(Article)

While the field of stem cell therapy has been in development for decades, regenerative medicine is now experiencing rapid progress fueled by scientific and technology advancements.

India regulators to re-inspect 147 drug plants

(News)

A joint team of central and state drug regulators in India will re-inspect 147 drug manufacturing plants that have been under scrutiny over the last two years.

U.S. FDA plans to re-inspect Sun Pharma’s Halol plant

(News)

The US FDA is expected to begin a critical re-inspection of Sun Pharma’s manufacturing facility at Halol in the second week of February., according to Economic Times’ sources.

Compliance Director Pleads Guilty to Conspiracy

(News)

The former compliance director for the now-defunct compounding pharmacy, Pharmakon Pharmaceuticals, has pleaded guilty to multiple criminal charges linked to the sale of adulterated drugs.

FDA Clears Sun Pharma Site

(News)

After receiving a Form-483 from the U.S. FDA earlier this year, Sun Pharma says its Dadra manufacturing facility has now been cleared by the regulator.

State of Packaging in the Pharma Industry

(Article)

Changes stemming from regulations, technological innovation and discovery bring about challenges for brand owners, packagers and OEMs

FDA Says Pfizer Failed to Investigate EpiPen Failures

(News)

According to an FDA warning letter, Meridian Medical Technologies, a Pfizer company that manufactures EpiPen auto-injectors, failed to properly investigate more than 100 complaints that the device malfunctioned.

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